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Publication: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy +
PURPOSE: This study was designed to determine whether oral retinol palmitate (vitamin A) can reduce the symptomsof radiation proctopathy. METHODS: A randomized, doubleblind trial comparing retinol palmitate (10,000 IU by mouth for 90 days) to placebo was conducted. Eligible patients were more than six months postpelvic radiotherapy and had significant symptoms as measured with the Radiation Proctopathy System Assessments Scale. Nineteen patients were randomized in total: ten to retinol palmitate and nine to placebo. The Radiation Proctopathy System Assessments Scale scores before and every 30 days for 90 days were measured. Five placebo nonresponders were crossed over to the retinol palmitate for another 90 days. Response was defined as a reduction in two or more symptoms by at least two Radiation Proctopathy System Assessments Scale points. RESULTS: Seven of ten retinol palmitate patients responded, whereas two of nine responded to placebo (P=0.057). Mean pre-post-treatment change in Radiation Proctopathy System Assessments Scale (Radiation Proctopathy System Assessments Scale) in the retinol palmitate group was 11 ± 5, whereas Radiation Proctopathy System Assessments Scale in the placebo group was 2.5 ± 3.6 (P=0.013, Mann-Whitney U test). Additionally, all five placebo nonresponders who were crossed over to treatment with retinal palmitate responded to treatment. CONCLUSIONS: In our trial, retinol palmitate significantly reduced rectal symptoms of radiation proctopathy, perhaps because of wound-healing effects. The current results can serve as the foundation for future trials examining retinol palmitate in the multi-institutional setting. +
Publication: A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment +
Purpose. The objective of this study was to determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared with attention control on health-related quality of life of women with advanced breast cancer undergoing chemotherapy, targeted and/or hormonal therapy.
Methods. Patient-caregiver dyads (N = 256) were randomized to four weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the four weeks, both groups had telephone symptom assessments, and intervention group had fidelity assessments. The intervention effects were assessed using linear mixed-effects models at weeks 5 and 11 for symptom severity and interference with daily activities, functioning, social support, quality of patient-caregiver relationship, and satisfaction with life.
Results. Significant reductions in average symptom severity (P = 0.02) and interference (P < 0.01) over 11 weeks were found in the reflexology group compared with control, with no group differences in functioning, social support, quality of relationship, or satisfaction with life at weeks 5 and 11. Stronger quality of relationship was associated with lower symptom interference in the entire sample (P = 0.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared with attention control were seen during weeks 2-5 but were reduced at Week 11.
Discussion. Efficacy findings of caregiver-delivered reflexology with respect to symptom reduction open a new evidence-based avenue for home-based symptom management. +
Publication: A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) +
Introduction: Both weight loss and low carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer (PC) models. Few human trials tested weight loss or LCD on PC.
Methods: We conducted a multi-site randomized 6-month trial of LCD vs control on PSA doubling time (PSADT) in PC patients with biochemical recurrence (BCR) after local treatment. Eligibility included BMI ≥24 kg/m2 and PSADT 3-36 months. LCD was instructed to eat ≤20g/carbs/day; controls were instructed to avoid dietary changes. Primary outcome was PSADT. Secondary outcomes included weight, lipids, glucose metabolism, and diet.
Results: Of 60 planned patients, the study stopped early after an interim analysis showed futility. 27 LCD and 18 controls completed the study. At 6-month, while both arms consumed similar protein and fats, LCD reduced carbohydrates intake (-117 vs. 8g, p<0.001) and lost weight (-12.1 vs. -0.50Kg, p<0.001). LCD reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose. Mean PSADT was similar between LCD (21 months) vs. control (15 months, p=0.316). In a post-hoc exploratory analysis accounting for pre-study PSADT, baseline PSA, primary treatment and hemoconcentration, PSADT was significantly longer in LCD vs. controls (28 vs 13 months, p=0.021). Adverse events were few, usually mild, and returned to baseline by 6-month.
Conclusions: Among BCR patients, LCD induced weight loss and metabolic benefits with acceptable safety without affecting PSADT suggesting LCD does not adversely affect PC growth and is safe. Given exploratory findings of longer PSADT, larger studies testing LCD on disease progression are warranted. +
Publication: A Randomized Study of Chemotherapy versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic Cancer +
Background: The recent advances in the analysis of tumor immunobiology suggest the possibility of biologically manipulating the efficacy and toxicity of cancer chemotherapy by endogenous or exogenous immunomodulating substances. Aloe is one of the of the most important plants exhibiting anticancer activity and its antineoplastic property is due to at least three different mechanisms, based on antiproliferative, immunostimulatory and antioxidant effects. The anti-proliferative action is determined by anthracenic and antraquinonic molecules, while the immunostimulating activity is mainly due to acemannan. Patients and Methods: A study was planned to include 240 patients with metastatic solid tumor who were randomized to receive chemotherapy with or without Aloe. According to tumor histotype and clinical status, lung cancer patients were treated with cisplatin and etoposide or weekly vinorelbine, colorectal cancer patients received oxaliplatin plus 5-fluorouracil (5-FU), gastric cancer patients were treated with weekly 5-FU and pancreatic cancer patients received weekly gemcitabine. Aloe was given orally at 10 ml thrice/daily. Results: The percentage of both objective tumor regressions and disease control was significantly higher in patients concomitantly treated with Aloe than with chemotherapy alone, as well as the percent of 3-year survival patients. Conclusion: This study seems to suggest that Aloe may be successfully associated with chemotherapy to increase its efficacy in terms of both tumor regression rate and survival time. +
Publication: A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients +
Background: Although low dietary intakes of antioxidant vitamins and minerals have been associated with higher risks of cancer, results of trials testing antioxidant supplementation for cancer chemoprevention have been equivocal. We assessed whether supplementation with antioxidant vitamins could reduce the incidence of second primary cancers among patients with head and neck cancer.
Methods: We conducted a multicenter, double-blind, placebo-controlled, randomized chemoprevention trial among 540 patients with stage I or II head and neck cancer treated by radiation therapy between October 1, 1994, and June 6, 2000. Supplementation with α-tocopherol (400 IU/day) and β-carotene (30 mg/day) or placebo began on the first day of radiation therapy and continued for 3 years after the end of radiation therapy. In the course of the trial, β-carotene supplementation was discontinued after 156 patients had enrolled because of ethical concerns. The remaining patients received α-tocopherol or placebo only. Survival was evaluated by Kaplan-Meier analysis. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). All statistical tests were two-sided.
Results: After a median follow-up of 52 months, second primary cancers and recurrences of the first tumor were diagnosed in 113 and 119 participants, respectively. The effect of supplementation on the incidence of second primary cancers varied over time. Compared with patients receiving placebo, patients receiving α-tocopherol supplements had a higher rate of second primary cancers during the supplementation period (HR = 2.88, 95% CI = 1.56 to 5.31) but a lower rate after supplementation was discontinued (HR = 0.41, 95% CI = 0.16 to 1.03). Similarly, the rate of having a recurrence or second primary cancer was higher during (HR = 1.86, 95% CI = 1.27 to 2.72) but lower after (HR = 0.71, 95% CI = 0.33 to 1.53) supplementation with α-tocopherol. The proportion of participants free of second primary cancer overall after 8 years of follow-up was similar in both arms.
Conclusions: α-Tocopherol supplementation produced unexpected adverse effects on the occurrence of second primary cancers and on cancer-free survival.
Publication: A phase II randomized double-blind placebo-controlled study of 6-gingerol as an anti-emetic in solid tumor patients receiving moderately to highly emetogenic chemotherapy +
6-Gingerol is a natural compound extracted from ginger. Preclinical studies demonstrated that 6-gingerol has an anti-emetic activity by inhibiting neurokinin-1, sero- tonin, and dopamine receptors. Several clinical trials examined crude ginger powder for preventing chemotherapy-induced nausea and vomiting (CINV), but none of them was conducted with a standardized bioactive compound. Patients who received moderately to highly eme- togenic adjuvant chemotherapy were randomized to receive 6-gingerol 10 mg or placebo orally twice daily for 12 weeks. Ondansetron, metoclopramide, and dexamethasone were given to all patients. The primary endpoint was complete response (CR) rate defined as no emesis or rescue treatment at any time. Eighty-eight patients were randomized to receive 6-gingerol (N = 42) or placebo (N = 46). Most patients received highly emetogenic chemotherapy (93%). Overall CR rate was significantly higher in 6-gingerol group as compared with that of the placebo (77 vs. 32%; P\0.001). The difference in means of appetite score was significant (P = 0.001) and more noticeable over time. Mean FACT-G score indicating quality of life was significantly higher (86.21) in 6-gingerol group at 64 days as compared with that of placebo group (72.36) (P \ 0.001). No toxicity related to 6-gingerol was observed. Patients treated with 6-gingerol reported significantly less grade 3 fatigue (2 vs. 20%; P = 0.020). 6-Gingerol significantly improved overall CR rate in CINV, appetite and quality of life in cancer patients receiving adjuvant chemotherapy. A phase III randomized study of 6-gingerol is warranted to confirm these results. +
Publication: A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue +
The aim of the study was to see if topical aloe vera gel would be beneficial in reducing the identified skin side-effects of radiation therapy, including erythema, pain, itching, dry desquamation, and moist desquamation, when compared with aqueous cream. The secondary aim was to assess the effect of other factors known to predict severity of radiation skin reaction, ie, breast size, smoking habit, and one or more drainages of lymphocele after surgery, on other skin side effects.
A Phase III study was conducted involving 225 patients with breast cancer after lumpectomy or partial mastectomy, who required a course of radiation therapy using tangential fields. Patients were randomized to either topical aloe vera gel or topical aqueous cream to be applied 3 times per day throughout and for 2 weeks after completion of radiation treatment. Weekly skin assessments were performed by nursing staff.
Aqueous cream was significantly better than aloe vera gel in reducing dry desquamation and pain related to treatment. Subjects with D cup or larger size breasts experienced significantly more erythema, regardless of treatment arm. For subjects who had undergone lymphocele drainage, the aloe vera group experienced significantly more pain than the aqueous cream group. Within the aqueous cream arm, smokers were significantly more likely to experience itching within the treatment field than were nonsmokers. Within the aloe vera arm, subjects who had undergone one or more lymphocele drainages after surgery were significantly more likely to experience erythema and itching within the treatment field than those who did not have drainage.
In this study, aloe vera gel did not significantly reduce radiation-induced skin side effects. Aqueous cream was useful in reducing dry desquamation and pain related to radiation therapy. +
Publication: A pilot clinical trial of radioprotective effects of curcumin supplementation in patients with prostate cancer +
Background: Patients with prostate cancer who accede to radiation therapy usually experience several side effects and these toxicities are sometimes dose limiting. Some previous in vitro and in vivo studies have proposed a radioprotective role for curcumin, the yellow pigment of turmeric.
Objectives: The purpose of this investigation was to assess the radioprotective effects of curcumin supplementation in patients with prostate cancer. Methods: Forty prostate cancer patients undergoing external beam radiotherapy (EBRT) were randomly assigned to curcumin group, taking 3 g/d curcumin (6 × 500 mg capsules of BCM95 n=20), or placebo group (n=20). Quality of life was assessed by the Persian version of the European Organization for Research and Treatment of Cancer prostate cancer-specific quality of life questionnaire (QLQ-PR25). Analysis of covariance was used to compare radiotherapy related symptoms between groups following the intervention, adjusted for baseline symptoms.
Results: No differences in urinary symptoms, bowel symptoms, treatment related symptoms and sexual activity were observed between the curcumin and placebo groups before the intervention. The change in urinary symptoms across the 20-week period differed significantly between groups (p=0.011) and patients in the curcumin group experienced much milder urinary symptoms compared with the placebo group. No group differences were observed in any other domain of the QLQ-PR25.
Conclusions: Curcumin can confer radioprotective effect in patients with prostate cancer who undergo radiation therapy through reducing the severity of radiotherapy related urinary symptoms. However supplementation with 3 g/ day curcumin could not reduce the severity of bowel symptoms or other treatment related symptoms. +
Publication: A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy +
The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy‑induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double‑blind, placebo‑controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per‑protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P=0.0463 and P=0.022; PPS, P=0.0076 and P=0.0064, respectively). Cancer‑associated fatigue was significantly alleviated following ALC treatment in the PPS (P=0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P=0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer‑associated fatigue and improving physical conditions. +
Publication: A randomised, controlled trial of the psychological effects of reflexology in early breast cancer +
Purpose: To conduct a pragmatic randomised controlled trial (RCT) to evaluate the effects of reflexology on quality of life (QofL) in women with early breast cancer.
Patients and methods: One hundred and eighty-three women were randomised 6 weeks post-breast surgery to self-initiated support (SIS) (comparator intervention), SIS plus reflexology, or SIS plus scalp massage (control for physical and social contact). Reflexology and massage comprised eight sessions at weekly intervals. The primary endpoint was 18 weeks post surgery; the primary outcome measure was the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy (FACT-B) – breast cancer version. The secondary endpoint was 24 weeks post surgery. Secondary outcome measures were the Hospital Anxiety and Depression Scale (HADS) and the Mood Rating Scale (MRS).
Results: At primary end-point, massage, but not reflexology, was significantly better than SIS on the TOI. Reflexology and massage were both better than SIS for MRS relaxation. Massage was better than reflexology and SIS for MRS easygoingness. At secondary endpoint, reflexology, but not massage, was better than SIS on the TOI and MRS relaxation. There were no significant differences between reflexology or massage. There were no significant between group differences in HADS anxiety and depression.
Self-reported use of out of study complementary therapies indicated that this was unlikely to have a significant effect on findings.
Conclusions: When compared to SIS, reflexology and massage have statistically significant, and, for reflexology, clinically worthwhile, effects on QofL following surgery for early breast carcinoma. +
Publication: A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results +
Aim: A randomized, open-label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN). Patients and methods: A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score. Results: The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16–5.47. Mean PNP scores were 4.99±1.33 for patients of group I and 10.47±10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation. Conclusion: Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity. +
Publication: A randomized double-blind, placebo-controlled trial of zinc sulfate supplementation for alleviation of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients +
OBJECTIVE: To determine the efficacy of zinc sulfate supplementation in reducing of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients. MATERIAL AND METHOD: One hundred forty four head and neck patients were enrolled in a randomized, double-blind, placebo-controlled trial. Patients who received radiation therapy alone or postoperative radiation therapy were eligible. Radiation therapy used conventional fractionation with 1.8 to 2.0 Gy perfraction, to total doses of 50 to 70 Gy over five to seven weeks. Drug and identically appearing placebo were self-administered 50 mg (10 cc) per meal, three times a day at mealtime. The zinc sulfate and placebo were administered beginning on the first day of radiation, and continued daily including weekends until radiation was completed Patients were evaluated before radiation, weekly during radiation and at the first month after completion of radiation. RESULTS: The baseline characteristics of patients, tumor, and treatment were not significantly different between the two groups. There were no statistically significant differences between the two treatment groups in frequency of patients experiencing greater than or equal to grade 2 oral mucositis andpharyngitis at each week during radiation and at the first month after completion of radiation. Six patients (17%) in the zinc sulfate and ten patients (23%) in placebo group developed grade 3 oral mucositis, which was not significantly different. Twenty-two patients (32%) in the zinc sulfate and nineteen patients (27%) in the placebo group developed grade 3 pharyngitis, which was not signifiibantly different. However there was no observation of grade 4 oral mucositis and pharyngitis in either group. Nausea and vomiting were mostly of mild degree. Adverse events were not statistically significant different between the two groups. CONCLUSION: It was concluded that zinc sulfate administered during head and neck radiation therapy produced no significant benefit in relieving radiation-induced oral mucositis and pharyngitis with acceptable side effects.
Publication: A randomized, controlled clinical trial to evaluate the effects of zinc sulfate on cancer patients with taste alterations caused by head and neck irradiation +
BACKGROUND: In uncontrolled clinical trials, the administration of oral zinc sulfate has been reported both to prevent and correct taste abnormalities in cancer patients receiving external radiotherapy (ERT) to the head and neck region. METHODS: Eighteen patients were randomized to receive either zinc sulfate tablets (a dose of 45 mg) or placebo tablets three times a day at the onset of subjective perception of taste alterations during the course of ERT and up to 1 month after ERT termination. Taste acuity was determined by measuring detection and recognition thresholds for four taste qualities. Intolerance of zinc sulfate or placebo administration was investigated, and the oral cavity was examined. All the evaluations were studied prior to, at weekly intervals during, and 1 month after ERT administration. RESULTS: Taste acuity for one or more taste qualities was already impaired before ERT. During ERT treatment, taste alterations were experienced at least once for a minimum of 3 of the 8 measured thresholds by 100% of the patients, and 33.3% of the patients became aware of some alteration within the first week of treatment. The patients treated with placebo experienced a greater worsening of taste acuity during ERT treatment compared with those treated with zinc sulfate. One month after ERT was terminated, the patients receiving zinc sulfate had a quicker recovery of taste acuity than those receiving placebo. Statistically significant differences between the two groups emerged for urea detection and sodium chloride recognition thresholds during ERT treatment and for sodium chloride, saccharose, and hydrogen chloride recognition thresholds after the termination of ERT treatment. CONCLUSIONS: This pharmacologic therapy is effective and well tolerated; it could become a routine in clinical practice to improve the supportive care of patients with taste alterations resulting from head and neck cancer. +
Publication: A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin +
Background: The activity of ginger in the management of chemotherapy-induced nausea and vomiting (CINV) has been suggested, but design inadequacies, heterogeneity of the population, small numbers and poor quality of tested products limit the possibility to offer generalizable results.
Patients and methods: We conducted a randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. CINV was assessed through daily visual-analogue scale and Functional Living Index Emesis questionnaires. The main objective was protection from delayed nausea; secondary end points included intercycle nausea and nausea anticipatory symptoms.
Results: In total, 121 patients received ginger and 123 placebo. Lung (49%) and head and neck cancer (HNC; 35%) were the most represented tumors. No differences were reported in terms of safety profile or compliance. The incidence of delayed, intercycle and anticipatory nausea did not differ between the two arms in the first cycle and second cycle. A benefit of ginger over placebo in Functional Living Index Emesis nausea score differences (day 6-day 1) was identified for females (P = 0.048) and HNC patients (P = 0.038).
Conclusions: In patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. The favorable effect observed on nausea in subgroups at particular risk of nausea (females; HNC) deserves specific investigation. +
Publication: A randomized, placebo controlled trial of oral zinc for chemotherapy-related taste and smell disorders +
Abnormalities in taste and smell are commonly reported in patients receiving chemotherapy and may hinder appetite, dietary intake, nutritional well-being, and quality of life. Oral zinc has been used to treat taste and smell abnormalities in several altered physiologic states, including renal failure, liver disease, head trauma, and pregnancy, with varying results. The authors conducted a double-blinded, placebo-controlled randomized clinic trial over 3 months. Eligible patients were those taking chemotherapy that had alterations in taste and/or smell. The measurement of the primary end point, improvement in altered taste and smell, was made using a 0-100 scale (100 describing no loss or distortion in taste and smell, and 0 describing the worst distortion or loss of taste and smell). Twenty-nine subjects were enrolled in each treatment group, of whom 31 were white, 26 African American, and 1 Native American. Forty-one patients were female. A wide range of cancer types was represented, with breast the most common (21 patients). The zinc dose was 220 mg orally twice daily (equivalent of 50 mg elemental zinc twice daily). There was no statistically significant improvement in loss or distortion of taste or smell with the addition of zinc. There was a trend toward improvement over time in all groups, except in the zinc group where there was a nonsignificant worsening in loss of smell over time. Zinc at standard doses did not provide significant benefit to taste or smell in patients receiving chemotherapy. +
Publication: Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy +
Objectives
To determine whether propionyl-l-carnitine (PLC) plus acetyl-l-carnitine (ALC) improves the effectiveness of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy.
Methods
We analyzed the data from 96 patients who had undergone bilateral nerve-sparing radical retropubic prostatectomy: 33 were given placebo (group 1), 32 used PLC 2 g/day plus ALC 2 g/day plus sildenafil 100 mg when needed (group 2), and 35 used sildenafil alone (group 3). The studied variables were sexual function (assessed through sexual behavior interviews and the International Index of Erectile Function), peak systolic velocity and end-diastolic velocity of cavernosal arteries (assayed by dynamic echo-color Doppler), the percentage of patients able to achieve a positive intracavernous injection test, and side effects.
Results
Placebo proved ineffective and sildenafil and sildenafil plus ALC and PLC proved effective. The International Index of Erectile Function-15 scores of the group 2 patients were significantly greater than those of group 3 in the following domains: erectile function, sexual intercourse satisfaction, orgasm, and general sexual well-being. The drugs did not significantly modify the score in the sexual desire domain or in the peak systolic velocity or end-diastolic velocity of the cavernosal arteries. Sexual behavior interviews revealed that 2 of 29 in group 1, 28 of 32 in group 2, and 20 of 39 in group 3 attained satisfactory sexual intercourse (P <0.01). Only group 2 had a significantly increased percentage of patients with a positive intracavernous injection test after therapy (36.4% versus 63.6%; P <0.01). ALC plus PLC did not significantly improve the side effects of sildenafil.
Conclusions
PLC and ALC proved to be safe and reliable in improving the efficacy of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy. +
Background: Nephrotoxicity is one of the most important limitations of cisplatin-based chemotherapies which associated with many complications and high mortality rate.
Objectives: To investigate the effect of lycopene on cisplatin-induced nephrotoxicity in patients with cancer.
Patients and Methods: In this double-blind, randomized clinical trial, 120 patients were randomly assigned to two groups, case (treated with lycopene + standard regimen of kidney injury prevention) and control (treated with only the standard regimen of kidney injury prevention). Lycopene was orally taken from 24 hours before to 72 hours after cisplatin administration. Blood urea nitrogen (BUN), serum creatinine (Cr), and glomerular filtration rate (GFR) were measured and recorded. The data were analyzed using SPSS.
Results: Changes in Cr were not significantly different between the two groups (P=0.131). However, a significant decreasing trend was seen in GFR during the study, which was more marked in the control group (P=0.004). BUN significantly decreased during the study (P=0.002), and a significant decrease of BUN on the day three in both groups was seen (P=0.001). However, BUN increased in the case group on the day 21 of treatment. The corresponding increase was less marked in the control group.
Conclusions: Lycopene can be considered a useful adjuvant therapy to decrease the complications due to cisplatin-induced nephrotoxicity in patients with cancer. +
Publication: An unblinded, randomised phase II study of platinum-based chemotherapy with vitamin B12 and folic acid supplementation in the treatment of lung cancer with plasma homocysteine blood levels as a biomarker of (...) +
Background: Vitamin B12 and folic acid (referred to as vitamin supplementation) improves the toxicity profile of pemetrexed containing regimens. Low baseline vitamin B12 and folate levels are reflected in a raised total homocysteine level (HC). Studies have suggested that pretreatment HC levels predict neutropenia toxicity. We have tested supplementation with vitamin B12 and folate in non-pemetrexed platinum-based regimens to decrease treatment-related toxicity and looked for a correlation between toxicity and change in homocysteine levels.
Patient and method: Eighty-three patients with advanced lung cancer and malignant mesothelioma were randomly assigned to receive platinum-based chemotherapy with (arm A) or without (arm B) vitamin B12 and folic acid supplementation. The primary end point was grade 3/4 neutropenia and death within 30 days of treatment. Secondary end points included quality of life, overall survival (OS) and the relationship between baseline and post supplementation HC levels and toxicity.
Results: In the intention-to-treat population, no significant difference was seen between the two groups with respect to chemotherapy-induced grade 3/4 neutropenia and death within 30 days of chemotherapy (36% vs 37%; p=0.966, emesis (2% vs 6%; p=0.9) or OS (12.3 months vs 7 months; p=0.41). There was no significant difference in survival rates by baseline HC level (p=0.9). Decrease in HC with vitamin supplementation was less frequent than expected. High baseline HC levels decreased with vitamin supplementation in only 9/36 (25%) patients (successful supplementation). Post hoc analysis showed that patients in arm A who were successfully supplemented (9/36=25%) had less neutropenic toxicity (0% vs 69%; p=0.02) compared to unsupplemented patients.
Conclusions: The addition of vitamin B12 and folic acid to platinum-containing regimens did not overall improve the toxicity, quality of life or OS. Rates of grade 3/4 neutropenia at 36/37% was as predicted. Further studies to increase the rate of successful supplementation and to further test the biomarker potential of post supplementation HC levels in predicting chemotherapy-induced neutropenia in platinum-based chemotherapy are warranted.
Publication: Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients +
There has been concern that long-term supplementation with highdose antioxidant vitamins, especially vitamin E (α-tocopherol), may increase all-cause mortality. We conducted a randomized controlled trial with α-tocopherol (400 IU/day) and β-carotene (30 mg/day) supplements among 540 head and neck cancer patients treated by radiation therapy. Supplementation with β-carotene was discontinued during the trial. The supplements were given during radiation therapy and for 3 additional years. During the follow-up (median 6.5 years), 179 deaths were recorded. All death certificates were obtained. All-cause and cause-specific mortality rates were compared between the 2 arms of the trial by Cox regression. All-cause mortality was significantly increased in the supplement arm: hazard ratio: 1.38, 95% confidence interval 1.03–1.85. Cause-specific mortality rates tended to be higher in the supplement arm than in the placebo arm. Our results concur with previous reports to suggest that high-dose vitamin E could be harmful. +
Publication: Beta-carotene Antioxidant Use During Radiation Therapy and Prostate Cancer Outcome in the Physicians’ Health Study +
Purpose: The safety of antioxidant supplementation during radiation therapy (RT) for cancer is controversial. Antioxidants could potentially counteract the pro-oxidant effects of RT and compromise therapeutic efficacy. We performed a prospective study nested within the Physicians’ Health Study (PHS) randomized trial to determine if supplemental antioxidant use during RT for prostate cancer is associated with an increased risk of prostate cancer death or metastases.
Methods and Materials: PHS participants (383) received RT for prostate cancer while randomized to receive beta-carotene (50 mg on alternate days) or placebo. The primary endpoint was time from RT to lethal prostate cancer, defined as prostate cancer death or bone metastases. The Kaplan-Meier method was used to estimate survival probabilities and the log-rank test to compare groups. Cox proportional hazards regression was used to estimate the effect of beta-carotene compared with that of placebo during RT.
Results: With a median follow-up of 10.5 years, there was no significant difference between risk of lethal prostate cancer with the use of beta-carotene during RT compared with that of placebo. +