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Publication: Biotherapy with the Pineal Immunomodulating Hormone Melatonin versus Melatonin plus Aloe vera in Untreatable Advanced Solid Neoplasms +
The possibility of natural cancer therapy has been recently suggested by advances in the knowledge of tumor immunobiology. Either cytokines such as IL-2, or neurohormones, such as the pineal indole melatonin (MLT), may activate anticancer immunity. In addition, immunomodulating substances have also been isolated from plants, particularly from Aloe vera. Preliminary clinical studies had already shown that MLT may induce some benefits in untreatable metastatic solid tumor patients, whereas, for the time being, no clinical trial has been performed with aloe products. We have carried out a clinical study to evaluate whether the concomitant administration of aloe may enhance the therapeutic results of MLT in patients with advanced solid tumors for whom no effective standard anticancer therapies are available. The study included 50 patients suffering from lung cancer, gastrointestinal tract tumors, breast cancer or brain glioblastoma, who were treated with MLT alone (20mg/day orally in the dark period) or MLT plus A. vera tincture (1 ml twice/day). A partial response (PR) was achieved in 2/24 patients treated with MLT plus aloe and in none of the patients treated with MLT alone. Stable disease (SD) was achieved in 12/24 and in 7/26 patients treated with MLT plus aloe or MLT alone, respectively. Therefore, the percentage of nonprogressing patients (PR + SD) was significantly higher in the group treated with MLT plus aloe than in the MLT gorup (14/24 vs. 7/26, p=0.05). The percent 1-year survival was significantly higher in patients treated with MLT plus aloe (9/24 vs. 4/26, p=0.05). Both treatments were well tolerated. This preliminary study would suggest that natural cancer therapy with MLT plus A. vera extracts may produce some therapeutic benefits, at least in terms of stabilization of disease and survival, in patients with advanced solid tumors, for whom no other standard effective therapy is available. +
Publication: Boswellia serrata Acts on Cerebral Edema in Patients Irradiated for Brain Tumors. A Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Trial +
BACKGROUND: Patients irradiated for brain tumors often suffer from cerebral edema and are usually treated with dexamethasone, which has various side effects. To investigate the activity of Boswellia serrata (BS) in radiotherapy-related edema, we conducted a prospective, randomized, placebo-controlled, double-blind, pilot trial.
METHODS: Forty-four patients with primary or secondary malignant cerebral tumors were randomly assigned to radiotherapy plus either BS 4200 mg/day or placebo. The volume of cerebral edema in the T2-weighted magnetic resonance imag- ing (MRI) sequence was analyzed as a primary endpoint. Secondary endpoints were toxicity, cognitive function, qual- ity of life, and the need for antiedematous (dexamethasone) medication. Blood samples were taken to analyze the serum concentration of boswellic acids (AKBA and KBA).
RESULTS: Compared with baseline and if measured immediately after the end of radiotherapy and BS/placebo treatment, a reduction of cerebral edema of >75% was found in 60% of patients receiving BS and in 26% of patients receiving placebo (P = .023). These findings may be based on an additional antitumor effect. There were no severe adverse events in either group. In the BS group, 6 patients reported minor gastrointestinal discomfort. BS did not have a significant impact on quality of life or cognitive function. The dexamethasone dose during radiotherapy in both groups was not statistically different. Boswellic acids could be detected in patients’ serum.
CONCLUSIONS: BS significantly reduced cerebral edema measured by MRI in the study population. BS could potentially be steroid-sparing for patients receiving brain irradiation. Our findings will need to be further validated in larger studies. +
Publication: Bromelain has significant clinical benefits after extraction of the third molar during chemotherapy in patients with hematologic tumor +
The purpose of this study was to investigate the application of bromelain in the treatment of pain, swelling, and limited mouth opening in patients with hematologic tumor after extraction of the third molar during chemotherapy. We recruited 72 patients with hematologic tumor who were treated by oral and maxillofacial surgery in our hospital, and third molar extraction was performed under local anesthesia. After extraction, patients in the control group were treated with cold - hot compress and patients in the experimental group were treated by oral administration of bromelain. One, three, and seven days after extraction, pain, swelling, and mouth opening in the experimental group improved compared to the control group. Additionally, the levels of IL-25 and TNF-α in the experimental group were significantly lower than in the control group, suggesting less inflammatory response. On the other hand, EGFR and β-FGF were significantly higher in the experimental group, supporting the activation of tissue repair pathways. Quality of life scores were significantly better in the experimental group. Overall, bromelain improves the quality of life, alleviates pain, swelling, and mouth opening, and effectively prevent postoperative complications in patients with hematologic tumors after third molar extraction during chemotherapy. +
Publication: Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture +
Purpose. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA) from which preliminary data showed promising results.
Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; 𝑛 = 14) with hydroelectric baths (HB, 𝑛 = 14), vitamin B1/B6 capsules (300/300mg daily; VitB, 𝑛 = 15), and placebo capsules (𝑛 = 17). The statistical power in this trial was primarily calculated for proving EAonly, so results of HB and VitB are pilot data.
Results. CIPNcomplaints improved by 0.8±1.2 (EA), 1.7±1.7 (HB), 1.6±2.0 (VitB), and 1.3±1.3 points (placebo) on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30) were found.
Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. +
Publication: Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial +
OBJECTIVE: Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream contaning boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients.
PATIENTS AND METHODS: The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale.
RESULTS: These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients.
CONCLUSIONS: Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy. +
Publication: Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects +
Purpose: The use of additional therapy with an oral enzyme preparation containing trypsin, chymotrypsin and papain has been suggested for the reduction of toxicity due to radiation therapy. This study was conducted to test the efficacy and tolerability of this enzyme combination in preventing or reducing the acute side effects of radiation therapy in patients with locally advanced cervical cancer.
Methods: A prospective, randomised, open, clinical trial was carried out on 120 patients (aged 24–85 years) with locally advanced, biopsy-proven carcinomas of the uterine cervix (stages IIa, IIb or IIIb). Patients received 50 Gy of external radiation therapy over a period of 5 weeks, followed by intra-cavitary brachytherapy (20–30 Gy). Patients assigned to the test group (60 patients) received additional treatment with enzymes. Patients were evaluated at weekly intervals for acute radiation therapy-related side effects, according to the RTOG/EORTC grading criteria, and then after the end of radiation therapy for another 8 weeks. Occurrence of adverse events, if any, was also recorded.
Results: The study revealed that the maximum extent of acute radiation side effects was reduced in the enzyme group: skin reactions (mean: 0.97 vs 1.68 in the control group, p<0.001), vaginal mucosal reactions (0.55 vs 0.85, p=0.10), genitourinary symptoms (0.93 vs 1.38, p<0.001) and gastrointestinal reactions (1.12 vs 1.30, p=0.12). The sum-scores during treatment, expressed as area under the curve, were significantly less in the enzyme treated patients. In the follow-up visits all observed side effects of radiation therapy were of lower intensity in the enzyme group than in the control group.
Conclusions: In patients with locally advanced cancer of the uterine cervix, oral enzyme therapy was found to be effective in significantly reducing radiation therapy-related side effects such as genitourinary symptoms, subcutaneous changes and reactions of the vaginal mucosa. +
Publication: Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial +
Purpose: To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation-induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. Materials and Methods: Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. Results: At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69 ± 7.77 days, benzydamine 15.85 ± 12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38 ± 10.75 days, benzydamine 23.54 ± 15.45 days). Mean changes of mucositis severity over time in both groups were statistically
similar and the effect of both treatments did not change signficantly with time (p = 0.09). +
Publication: Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy +
Context
One of the major toxicities of paclitaxel is peripheral neuropathy, primarily affecting sensory components more than motor and autonomic functions. Acetyl-L-carnitine (ALC), methylcobalamine, vitamin E, and glutamine have been tested in various trials against placebos. This randomized study was conducted to compare the efficacy of these four drugs in relieving symptoms of paclitaxel-induced peripheral neuropathy.
Settings and Design
This single-institution, prospective, multi-arm, randomized study was conducted per the Helsinki protocol with local ethical committee clearances.
Materials and Methods
Patients with carcinomas of the lung, breast, and ovary were recruited to receive paclitaxel 175 mg/m² intravenously as a 1st or 2nd line drug. They were randomized into one of four treatment arms: Arm A (vitamin E 400 mg OD from day 1 of the cycle to 1 month after completion of clinical trial [CT]); Arm B (ALC 250 mg OD from day 1 to day 7 in each cycle of CT); Arm C (glutamine 10 mg TDS from day 2 to day 5 in each cycle); and Arm D (methylcobalamine 500 μg TDS from day 1 of the first cycle to 1 month after completion of CT). All drugs were started at the onset of symptoms. CTCAE v 4.02 was used for assessments.
Statistical Analysis Used
Changes in scores for sensory, motor, and pain symptoms over the study period were compared using repeated measures of the General Linear Model of SPSS version 17.
Results
A total of 22, 24, 21, and 23 patients were eligible for analysis in the four arms. Vitamin E produced comparable relief to methylcobalamine in alleviating peripheral neuropathy. Both vitamin E and methylcobalamine were superior to glutamine and ALC in relieving sensory, motor, and pain symptoms. Glutamine and ALC had comparable effects.
Conclusions
All four drugs were effective in alleviating symptoms, with vitamin E and methylcobalamine being more effective than glutamine and ALC in controlling symptoms of paclitaxel-induced peripheral neuropathy.
Publication: Comparing the Effectiveness of Green Tea versus Topical Metronidazole Powder in Malodorous Control of Fungating Malignant Wounds in a Controlled Randomised Stud +
Aim: To test the efficacy of green tea with that of conventional topical metronidazole powder by comparing the rate of malodorous score reduction using the verbal numeric scale (VNS).
Methods: This was a prospective randomised experimental study comparing two types of odour control agents used for treating malodorous fungating malignant wounds in a tertiary hospital in Singapore. Patients were randomised to either control (metronidazole power) or treatment (green tea) group and was follow-up with a
daily dressing for a week by a designated nurse. Both patient and designated nurse would rate the malodorous score daily on a VNS of 0 (no smell) to 10 (worst smell that one can imagine).
Results: Thirty cancer patients with malodorous fungating wounds were randomised into either treatment (n=15) or control group (n=15). The location of wounds were breast (n=24), neck (n=2), groin (n=2), spine (n=1) and anus (n=1). All patients in both groups showed improvement in odour control by Day 7. Treatment group was as effective as control group and there was no statistical significance (p>0.05) to demonstrate which treatment is more superior.
Conclusion: Green tea dressing is as effective as conventional topical metronidazole powder in controlling odour. Green tea is cheap, easily available and has no risk of drug resistance over long term use. Alternatively, it can also be used interchangeably with metronidazole powder to reduce the risk of drug resistance. +
Publication: Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…) +
Purpose
To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and Placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS).
Patients and Methods
Adult patients with advanced cancer, CACS, weight loss (≥ 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks.
Results
Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% ≥ 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients
receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms.
Conclusion
CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients’ appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated. +
Publication: Comparison of the Complications of Platinum-Based Adjuvant Chemotherapy With and Without Ginger in a Pilot Study on Ovarian Cancer Patients +
Objectives: The principal treatment of ovarian cancer is surgery with or without chemotherapy. The chemotherapy, however, might be ineffective and long with serious side-effects. To obviate these shortcomings, more efficient and safer medications are required, among which ginger has recently gained popularity because of its anti-cancer properties. This study aims to compare outcomes and side-effects of adjuvant chemotherapy with and without ginger in ovarian cancer patients.
Materials and Methods: A total of 49 patients (20 patients in case group and 29 patients in control group) with stage I to III, histopathologically proved ovarian cancer underwent cytoreductive surgery followed by platinum-based adjuvant chemotherapy with and without investigator-prepared oral ginger capsules (2 g per day for 6 cycles). Potential side-effects, poor 12-month outcome (serum CA125 levels >35U, radiologic evidence of metastasis and recurrence, or death), and 12-month disease-free survival were documented and compared between the 2 groups.
Results: Poor outcome including serum CA125>35, metastasis, recurrence or death was documented more common in control group (69% versus 40%). metastasis frequency confirmed by computerized tomography (CT) scan 6 month after treatment was significantly lower in case group (P = 0.04). There was no significant difference regarding mortality and disease free survival during one year follow-up after treatment between 2 groups (P = 0.55). Chemotherapy complications such as nausea, vomiting, weight loss, and peripheral neuropathy were detected in case group less than control group but the difference was not significant.
Conclusion: Oral administration of ginger is along with a significantly better 12-month outcome in patients on chemotherapy because of ovarian cancer, and accordingly, considering its safety, its administration is recommended. +
Publication: Curcumin for radiation dermatitis: a randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patients +
Radiation dermatitis occurs in approximately 95% of patients receiving radiotherapy (RT) for breast cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the ability of curcumin to reduce radiation dermatitis severity in 30 breast cancer patients. Eligible patients were adult females with noninflammatory breast cancer or carcinoma in situ prescribed RT without concurrent chemotherapy. Randomized patients took 2.0 grams of curcumin or placebo orally three times per day (i.e., 6.0 grams daily) throughout their course of RT. Weekly assessments included Radiation Dermatitis Severity (RDS) score, presence of moist desquamation, redness measurement, McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaire. The 30 evaluable patients were primarily white (90%) and had a mean age of 58.1 years. Standard pooled variances t test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS =2.6 vs. 3.4; P =0.008). Fisher’s exact test revealed that fewer curcumin-treated patients had moist desquamation (28.6% vs. 87.5%; P =0.002). No significant differences were observed between arms for demographics, compliance, radiation skin dose, redness, pain or symptoms. In conclusion, oral curcumin, 6.0 g daily during radiotherapy, reduced the severity of radiation dermatitis in breast cancer patients. +
Die Strahlentherapie stellt eine wirksame Behandlungsvariante der Kopf-Halskarzinome dar. Dies sowohl als Teletherapie (prä- oder postoperativ) als auch in Form der sogenannten Brachytherapie wie z.B. die interstitielle Radiotherapie im „after loading“-Verfahren (siehe Kapitel „Radiotherapie von Kopf-Hals-Karzinomen“) +
Publication: Discrepancy of the effects of zinc supplementation on the prevention of radiotherapy-induced mucositis between patients with nasopharyngeal carcinoma and those with oral cancers: subgroup analysis of a double-blind, randomized study +
The purpose of this study was to determine the effect of zinc supplementation on radiation-induced mucositis in patients with nasopharyngeal carcinoma (NPC) and those with oral cancers (OC). A total of 100 patients with head and neck cancers engaged in a randomized double blind study. All participants were placed into two randomized groups (experimental and control). The experimental group received a standard dose of zinc supplements, and the control group was given a placebo. Subgroup analyses were performed between 40 NPC and 43 OC patients. It was found that patients with OC in the control group developed Grade 2 and Grade 3 mucositis sooner than those in the experimental group. However, the benefits were not found to extend to patients with NPC. The results indicated that zinc supplementation prescribed in conjunction with radiotherapy postponed the development of severe mucositis solely for patients with OC. The pretreatment oral mucosa condition and areca chewing habit might account for such discrepancy. +
Publication: Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial +
Purpose: Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic radiotherapy?
Material and methods: Fifty-six patients with an indication for adjuvant pelvic irradiation after curative surgery were double-blind randomized. All patients took 3×4 capsules study medication daily during radiotherapy. Twenty-eight patients in the enzyme group (EG) received capsules containing papain, trypsin and chymotrypsin, 28 in the placebo group (PG) received placebo capsules. All patients were irradiated with 5×1.8 Gy weekly to 50.4 Gy using four-field-box technique after CT-based planning. Primary objective was the grade of diarrhea, nausea, vomiting, fatigue and epitheliolysis during radiotherapy. Secondary objectives were the number of supportive medications and treatment interruptions due to acute toxicity.
Results: None/mild diarrhea: 43% EG, 64% PG. Moderate/severe diarrhea: 57% EG, 36% PG (P=0.11). Mean duration: 11 days in EG, 10 days in PG. None/mild nausea: 93% EG, 93% PG. Moderate/severe nausea: 7% EG, 7% PG. None/mild vomiting: 100% EG, 97% PG. None/mild fatigue: 82% EG, 93% PG. Moderate/severe fatigue: 18% EG, 7% PG (P=0.23). None/mild epitheliolysis: 75% EG, 93% PG. Moderate/severe epitheliolysis: 25% EG, 7% PG (P=0.16). Treatment interruption (mean days): 2.44 in EG, 1.46 in PG. Number of supportive medication: 29 in EG, 19 in PG.
Conclusions: The prophylactic use of proteolytic enzymes does not reduce acute toxicities, treatment interruptions and number of supportive medication and therefore does not improve tolerance of adjuvant pelvic radiotherapy. +
Publication: Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? +
Objectives Salivary gland impairment after high-dose radioiodine (<sup>131</sup>I) treatment is well recognized. The aim of this study was to determine the protective effect of vitamin E on radiation-induced salivary gland dysfunction in patients undergoing <sup>131</sup>I treatment for differentiated thyroid cancer. Methods Thirty-six patients with differentiated thyroid carcinoma were enrolled in this study. They were randomly divided into two groups before postsurgical ablation therapy with 3700–5550MBq <sup>131</sup>I: the control group, comprising 17 patients, and the vitamin E group, comprising 19 patients. All 19 patients in the experimental group received vitamin E at a dose of 800 IU/day for a duration of 1 week before to 4 weeks after <sup>131</sup>I therapy and the 17 patients in the control group received a placebo for the same duration. Salivary gland function was assessed using salivary gland scintigraphy with intravenous injection of 370MBq <sup>99m</sup>Tc-pertechnetate in two phases, one immediately before and the other 6 months after <sup>131</sup>I ablative therapy. First-minute uptake ratio, maximum uptake ratio, maximum secretion percentage, and excretion fraction (EF) of each salivary gland were measured and compared between the study phases for the two groups. Results There was no significant difference between preablative and postablative salivary scintigraphic indices in the experimental vitamin E group, whereas maximum secretion percentage and EF of the right submandibular gland and EF of the left parotid gland were significantly decreased in the control group. There was also a higher significant decrease in the EF of the left parotid gland in the control group compared with the vitamin E group. Conclusion Vitamin E consumption may be associated with a significant protective effect against radiation-induced dysfunction in salivary glands following single-dose <sup>131</sup>I therapy in patients with differentiated thyroid cancer.
Publication: Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4) +
PURPOSE: Taste alterations (dysgeusia) are well described in head and neck cancer patients who undergo radiotherapy (RT). Anecdotal observations and pilot studies have suggested zinc may mitigate these symptoms. This multi-institutional, double-blind, placebo-controlled trial was conducted to provide definitive evidence of this mineral's palliative efficacy. METHODS AND MATERIALS: A total of 169 evaluable patients were randomly assigned to zinc sulfate 45 mg orally three times daily vs. placebo. Treatment was to be given throughout RT and for 1 month after. All patients were scheduled to receive > or =2,000 cGy of external beam RT to > or =30% of the oral cavity, were able to take oral medication, and had no oral thrush at study entry. Changes in taste were assessed using the previously validated Wickham questionnaire. RESULTS: At baseline, the groups were comparable in age, gender, and planned radiation dose (<6,000 vs. > or =6,000 cGy). Overall, 61 zinc-treated (73%) and 71 placebo-exposed (84%) patients described taste alterations during the first 2 months (p = 0.16). The median interval to taste alterations was 2.3 vs. 1.6 weeks in the zinc-treated and placebo-exposed patients, respectively (p = 0.09). The reported taste alterations included the absence of any taste (16%), bitter taste (8%), salty taste (5%), sour taste (4%), sweet taste (5%), and the presence of a metallic taste (10%), as well as other descriptions provided by a write in response (81%). Zinc sulfate did not favorably affect the interval to taste recovery. CONCLUSION: Zinc sulfate, as prescribed in this trial, did not prevent taste alterations in cancer patients who were undergoing RT to the oral pharynx. +
Publication: Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer +
Background: There is no widely accepted intervention in the prevention of acute mucositis during chemoradiotherapy for head and neck carcinoma. In the present double-blind study, we tested 4 natural agents, propolis, aloe vera, calendula, and chamomile versus placebo. Methods: Patients undergoing concomitant chemo-intensity-modulated radiotherapy (IMRT) were given natural agent or matched placebo; grade 3 mucositis on physical examination according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was the primary endpoint. Various covariates were tested at logistic regression, including the individual amount of mucosa receiving at least 9.5 Gy per week (V9.5w). Results: One hundred seven patients were randomized from January 2011 to July 2014, and 104 were assessable (51%-49% were assigned to the placebo group and 53%-51% were assigned to the natural agent). Overall, 61 patients developed peak grade 3 mucositis with no difference between arms (p=.65). Conversely, V9.5w (p=.007) and primary site (p=.037) were independent predictors. Conclusion: The selected natural agents do not prevent mucositis, whereas the role of V9.5w is confirmed. +
Publication: Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT Investigators +
Purpose: To compare the safety and activity of DN-101, a new high-dose oral formulation of calcitriol designed for cancer therapy, and docetaxel with placebo and docetaxel.
Patients and Methods: Patients with progressive metastatic androgen-independent prostate cancer and adequate organ function received weekly docetaxel 36 mg/m<sup>2</sup> intravenously for 3 weeks of a 4-week cycle combined with either 45 μg DN-101 or placebo taken orally 1 day before docetaxel. The primary end point was prostate-specific antigen (PSA) response within 6 months of enrollment, defined as a 50% reduction confirmed at least 4 weeks later.
Results: Two hundred fifty patients were randomly assigned. Baseline characteristics were similar in both arms. Within 6 months, PSA responses were seen in 58% in DN-101 patients and 49% in placebo patients (p = .16). Overall, PSA response rates were 63% (DN-101) and 52% (placebo), p = .07. Patients in the DN-101 group had a hazard ratio for death of 0.67 (p = .04) in a multivariate analysis that included baseline hemoglobin and performance status. Median survival has not been reached for the DN-101 arm and is estimated to be 24.5 months using the hazard ratio, compared with 16.4 months for placebo. Grade 3/4 adverse events occurred in 58% of DN-101 patients and in 70% of placebo-treated patients (p = .07). Most common grade 3/4 toxicities for DN-101 versus placebo were neutropenia (10% v 8%), fatigue (8% v 16%), infection (8% v 13%), and hyperglycemia (6% v 12%).
Conclusion: This study suggests that DN-101 treatment was associated with improved survival, but this will require confirmation because survival was not a primary end point. The addition of weekly DN-101 did not increase the toxicity of weekly docetaxel. +
Publication: Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy +
Background: Radiation-induced discomfort is frequently observed during pelvic radiotherapy. This study was performed to determine the effect of a green tea tablet to reduce the incidence of radiation-induced diarrhea and vomiting in patients with abdomen and pelvic malignancy. Materials and Methods: This randomized controlled clinical trial recruited 42 patients with abdomen and pelvic malignancy considered for treatment with 50 Gy radiotherapy, randomly assigned to the green tea tablet 450 mg (n = 21) or placebo
group (n = 21) for 5 weeks. Acute gastrointesinal complications (Diarrhea and vomiting) were weekly assessed using Common Toxicity Criteria of the National Cancer Institute version 3.0 and functional living index emesis, respectively. Two-sample t-tests, Pearson’s Chi-square, Mann-Whitney U-test, and Friedman were used for analysis. Results: There was a significant difference in frequency of reported diarrhea between two groups of study at the end of study (P < 0.002). About 81% of patients in green tea group reported no history of diarrhea at week 5. The treatment group have reported no history of severe diarrhea during radiotherapy. There was no significant difference between two groups of study in frequency of vomiting throughout the study, but 9.5% of cases in placebo group showed severe vomiting. Conclusion: Green tea contains a high concentration of catechins could be eff ective in decreasing the frequency and severity of radiotherapy induced diarrhea. Green tea (450 mg/day) could be considered to be a safe for prevention
diarrhea and vomiting in patients undergoing pelvic or abdomen radiotherapy. +