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Publication: The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 +
Background: Radioiodine (<sup>131</sup>I) therapy is usually performed in patients with differentiated thyroid cancer (DTC). Although <sup>131</sup>I is generally considered safe, genotoxic damage has been demonstrated both in vivo and in vitro. The aim of the current study was to evaluate the effect of Ginkgo biloba extract (GBE) on the time-course of appearance, after <sup>131</sup>I therapy for DTC, of plasma factors with chromosome-damaging properties (so-called “clastogenic” factors (CFs)) and of micronuclei (MN) in lymphocytes.
Methods: Twenty-three patients (median age 42 years, range 18–73) with DTC receiving <sup>131</sup>I activity (3.7 GBq) for thyroid remnant ablation were randomly assigned to receive GBE (120 mg/day for one month; n=10) or placebo (n=13) in a double-blind manner. Blood samples were taken at various intervals (from baseline to 90 days) after <sup>131</sup>I therapy. The frequency of MN in blood lymphocytes was determined, and CFs were assayed in plasma by a method that used MN increase in lymphocytes from an healthy donor as the endpoint of the assay.
Results: MN in blood lymphocytes increased significantly after <sup>131</sup>I treatment in the placebo group, peaking at the 7th day (p=0.002) and slowly declining thereafter. In contrast, in similarly treated patients who were also treated with GBE both before and after <sup>131</sup>I treatment, a significant increase of blood lymphocyte MN level was not observed. In addition, only the placebo group showed a significant, progressive increase in CFs activity. This peaked at the 14th day (p=0.003 vs. baseline) and was still noted for the last plasma sample. The differences in the change in lymphocyte MN and CFs activity between the placebo and GBE-treated groups were significant (p<0.01 and p<0.05, respectively). Thyroid function tests, including serum thyroglobulin (Tg) and anti-Tg antibody levels, were never significantly different.
Conclusions: GBE may protect from possible oxidative and genotoxic damage associated with <sup>131</sup>I treatment in patients requiring <sup>131</sup>I therapy for thyroid cancer, without affecting the clinical outcome. Further studies with larger cohorts of patients are needed to confirm this report and verify the beneficial effect of GBE in patients requiring <sup>131</sup>I therapy, particularly for those in whom repeated treatments and high activities of <sup>131</sup>I are required.
Publication: The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy +
Purpose/objectives: To determine whether the use of mild soap and aloe vera gel versus mild soap alone would decrease the incidence of skin reactions in patients undergoing radiation therapy.
Data sources: Prospective, randomized, blinded clinical trial.
Setting: Radiation therapy outpatient clinic in a cancer center affiliated with a major teaching medical facility.
Sample: The mean age of the participants was 56 years. The group consisted of Caucasians (74%) and African Americans (26%). The ethnic mix was non-Hispanic (65%) and Hispanic (35%).
Methods: Prophylactic skin care began on the first day of radiation therapy. Patients cleansed the area with mild, unscented soap. Patients randomized into the experimental arm of the trial were instructed to liberally apply aloe vera gel to the area at various intervals throughout the day.
Findings: At low cumulative dose levels < or = 2,700 cGy, no difference existed in the effect of adding aloe. When the cumulative dose was high (> 2,700 cGy), the median time was five weeks prior to any skin changes in the aloe/soap arm versus three weeks in the soap only arm. When the cumulative dose increases over time, there seems to be a protective effect of adding aloe to the soap regimen.
Implications for nursing practice: Skin products used to treat radiation dermatitis vary among institutions. Nurses should be aware that some patients may be predisposed to skin problems. Nurses must be aware of newly developed products and research regarding these products so that effective treatment can be instituted. +
Publication: The effect of ginger extract on radiotherapy-oriented salivation in patients with xerostomia: A double-blind controlled study +
Studies conducted on various properties of ginger showed that it has parasympathetic activity and can stimulate the salivary secretion. This study was aimed to evaluate methanolic ginger extract’s effect on the rate of salivary secretion and xerostomia improvement in patients who underwent the radiotherapy in Ahvaz Golestan hospital in 2014(Southwest of Iran). This double-blind intervention trial was conducted on 40 patients with a history of head and neck radiotherapy. Data collection tools included two questionnaires designed using other similar studies. After the preparation of the capsules (500mg) containing total extract of ginger and placebo, the whole saliva of the patients was measured and they were asked to complete the questionnaire of xerostomia symptoms. Then the capsules randomly were given to the two groups of patients and they were asked to take one capsule every six hours. After two weeks, the whole saliva of patients was measured again and they were asked to respond to questions of the first questionnaire again. Furthermore, patients responded the second questionnaire to assess the effects of the drug on xerostomia symptoms. The data were analyzed using SPSS version 20. The saliva secretion level in the ginger group was significantly higher than in the placebo group (P<0.05). After two weeks, many of the xerostomia symptoms were healed and patients declared that ginger had positive effects on improvement of their problems. Patients also tend to continue for taking ginger. These findings showed that ginger can improve the xerostomia symptoms through increasing the rate of salivary secretion in these patients. +
Publication: The effect of pyridoxine for prevention of hand-foot-syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine: A randomized study +
Background/Aims: To determine the effect of the pyridoxine for prevention of hand-foot syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine.
Methodology: Colorectal cancer patients scheduled for capecitabine chemotherapy as adjuvant setting were randomly assigned to with or without concurrent oral pyridoxine (60 mg/d) groups. Patients were monitored whether being a development of National Cancer Institute Common Toxicity Criteria grade 2 or worse HFS until chemotherapy ended.
Results: Sixty patients were enrolled in this study. Relative dose intensity was 89.5% in total. The median number of chemotherapy cycles to grade 2 or worse HFS was four in both groups. Grade 2 or worse HES developed in 18 (60.0%) of 30 control patients and in 18 (60.0%) of 30 pyridoxine patients. The cumulative dose of capecitabine to grade 2 or worse HFS was not different between the two groups.
Conclusions: Pyridoxine is not effective in prevention of capecitabine-associated HFS. +
Background: This study aims to identify the effect of reflexology on the quality of life in patients with breast cancer.
Methods: The population of the study conducted comprised of 60 patients; 30 forming the control and 30 the experimental groups (30 experimental, 30 control). Patient identification forms and EORTC QLQC30 Quality of Life Scale were used to collect the data. Statistical analysis used: The data obtained as a result of the study were assessed via computer using ‘Statistical Package for Social Science 21.0’ software.
Results: The results of the experiment demonstrated that the within-group symptom total score average of the patients in the experiment/treatment group decreased after the reflexology treatment; while the general health and functional total score averages in the treatment group increased; and the difference between pretest and posttest measurements was statistically significant (p 1⁄4 0.000).
Once symptom, functional, and general health total score averages from the posttest measurement are compared across treatment and control groups, symptom total score average of the patients in the treatment group turned out to be significantly lower than that of the patients in the control group (p 1⁄4 0.001). In terms of functional and general health score averages, patients in the treatment group scored significantly higher than those in the control group (p 1⁄4 0.000).
Conclusion: Reflexology was found to reduce the symptoms experienced by breast cancer patients, while at the same time increasing the functional and general health status. +
Publication: The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer +
Purpose: Vaginal atrophy is one of the most common side effects of using tamoxifen in women with breast cancer. Hormone therapy for vaginal atrophy is prohibited in these women. The present study was conducted to investigate the effect of vitamin D and E vaginal suppositories on vaginal atrophy in women with breast cancer receiving tamoxifen.
Methods: Women under breast cancer management receiving tamoxifen and showing symptoms of vaginal atrophy were randomized triple-blind to an 8-week trial on vaginal suppository vitamin E or vitamin D or placebo administered every night before bedtime. The genitourinary atrophy self-assessment tool was administered, and pH was measured in all three groups before the intervention and at the end of weeks 2, 4, and 8 of the intervention. The Vaginal Maturation Index (VMI) was also measured before the intervention and at the end of the eighth week. Data were analyzed with paired t tests, repeated measures analysis of variance, and chi-square test.
Results: Thirty-two patients were randomized in each group. The results obtained showed an increase in the VMI by the end of the eighth week of the intervention in the groups receiving the vitamin D and E vaginal suppositories compared with the placebo group (P < 0.001). The vaginal pH also reduced in both groups compared with that in the placebo group (P < 0.001). The symptoms of self-reported genitourinary atrophy also improved in the two intervention groups compared with those in the placebo group by the end of the eighth week (P < 0.001).
Conclusion: These data support that vitamin D and E vaginal suppositories were beneficial in improving vaginal atrophy in women with breast cancer receiving tamoxifen. Given the prohibition on hormone therapy in these women, the suppositories can be used as an alternative therapy to improve these symptoms. +
Publication: The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
Background: To investigate the effect of zinc sulphate for prophylaxis of radiation‐induced oral mucositis in patients with head and neck cancer. Materials And Methods: In the department of Radiation Oncology, Ankara Numune Education and Research Hospital, 40 patients with head and neck cancer were selected randomly to receive either Zinco‐C 25 mg, four tablets daily or control group who did not receive any drug. The patients were treated with Cobalt 60 teletherapy unit with conventional fractionation of 2 Gy/fraction. Oral mucositis were assessed by using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring criteria, before treatment, once a week during treatment and after treatment. Statistical analyses were performed using the SPSS for Windows software package. Results: In all patients, rates of grade 0, 1, 2, 3 mucositis were found 37.5%, 32.5%, 27.5% ve 2.5% respectively. Grade 0, 1, 2, 3 esophagitis were found 20%, 40%, 32.5%, 7.5%, respectively. Grade 4 mucositis and esophagitis were not detected in any patients. Between two groups, no relation was found between giving zinc and mucositis/esophagitis. Before radiotherapy, plasma zinc levels were lower in 20 patients (%50). In control group patients, post treatment serum zinc levels were significantly lower than zinc sulphate group (p=0.05). Incidence of mucositis and esophagitis was decreased when serum zinc levels were normal before and after treatment, though this was not statistically significant (p=0.476, p= 0.351 respectively). Conclusion: We found that zinc sulphate prophylaxis does not reduce incidence of mucositis and esophagitis. This may be due to before radiotherapy serum zinc levels in the patients who were given zinc were generally lower than control group. In other hand we showed that in control group patients, post treatment serum zinc levels were significantly lower than zinc sulphate group (p=0.05). +
Publication: The effectiveness of inhaled ginger essential oil in improving dietary intake in breast-cancer patients experiencing chemotherapy-induced nausea and vomiting +
Background: Evidence suggests the use of complementary therapies may help in relieving the adverse effects of cancer-related treatment, including nausea.
Objectives: To evaluate the effectiveness of inhaled ginger essential oil (EO) in improving dietary intake in women with breast cancer experiencing chemotherapy-induced nausea and vomiting (CINV). General perception on the use of ginger aromatherapy was also evaluated.
Methods: A single-blind, randomised, placebo-controlled, crossover study was conducted in two oncology clinics in Peninsular Malaysia. Women received 5 days of aromatherapy treatment using either ginger EO or fragrance-matched placebo [ginger fragrance oil (FO)] in an order dictated by the treatment group sequence. The following aspects were evaluated: nutritional status (BMI, nutritional requirement, dietary intake) and general perception of aromatherapy. Results Sixty women completed the study (age=47.3 ±9.26 years; receiving highly emetogenic chemotherapy=86.7%; BMI=25.5 ±5.4 kg/m2). Energy intakes were significantly higher after patients were treated with ginger EO than ginger FO at day 3 (P=0.015) and day 5 (P=0.002). Significant improvements in energy intake were also observed over time [F(2,57)=54.21, P<0.001], reaching almost 90% of the energy requirement 5 days’ post-chemotherapy. Inhaled aromatherapy using ginger EO was rated marginally more helpful than the ginger FO (63.3% vs. 61.6%). Being delivered via a necklace, the treatment method was considered feasible for participating women.
Conclusion: The use of inhaled ginger EO for CINV could possibly help patients resume their dietary intake. This complementary treatment was also favourably received by the participating women. +
Publication: The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled study +
Background: Aloe vera has been widely used to treat various conditions such as sunburn or radiation-related dermatitis, mucositis, or esophagitis. It is suggested that Aloe vera may be benefit for radiation-induced mucositis. Objective: To evaluate the efficacy of oral aloe vera juice in the alleviation of radiation induced mucositis in head and neck cancer patients using a double-blind, randomized controlled trial. Methods and materials: Sixty-one eligible head and neck cancer patients, who received conventional radiation therapy at Ramathibodi Hospital, were randomized to receive oral Aloe vera juice or placebo. Mucosal reaction was assessed during the course of radiation using the Radiation Therapy Oncology Group grading system. Results: Patient baseline characteristics were identical in Aloe vera juice and placebo groups except in the gender. The incidence of severe mucositis was significantly lower in the aloe vera group compared with the placebo group (53% vs. 87%, p =0.004). However, there was no significant difference in the time-duration to severe mucositis development. No adverse effects related to the drug were observed. Conclusion: Oral aloe vera juice was beneficial in alleviating the severity of radiation-induced mucositis and without side effects. The Aloe vera juice may be an alternative agent treating radiation-induced mucositis in patients with head and neck cancers. +
Publication: The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial +
Oral mucositis (OM) is a complication of high-dose chemotherapy (HDC) followed by hematopoietic SCT (HSCT) with few effective treatments. Selenium has a cytoprotective role via the glutathione peroxidase (Glu.Px) enzyme and prevents chemotherapy-induced toxicities. We performed a double-blind, randomized, placebo-controlled study to evaluate the efficacy of selenium on the prevention of OM in 77 patients with leukemia, undergoing allogeneic HSCT. Thirty-seven patients received oral selenium tablets (200 mcg twice daily) from the starting day of HDC to 14 days after transplantation. OM was evaluated daily for 21 days after transplantation according to World Health Organization oral toxicity scale. The incidence of severe OM (grades 3–4) was significantly lower in the selenium group (10.8% vs. 35.1%, p<0.05). We noted that the duration of objective OM (grades 2–4), excluding patient’s self-declaration (grade 1), was significantly shorter in the selenium group (3.6±1.84 vs. 5.3±2.2 days, p=0.014). Significant elevations in serum selenium level and plasma Glu.Px activity were observed 7 and 14 days after transplantation compared with baseline in the selenium group. We conclude that selenium can reduce the duration and severity of OM after HDC. +
Publication: The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer +
Purpose
Patients undergoing treatment for cancer often report problems with their cognitive function, which is an essential component of health-related quality of life. Pursuant to this, a two-arm randomized, placebo-controlled, double-blind, phase III clinical trial was conducted to evaluate Ginkgo biloba (EGB 761) for the prevention of chemotherapy-related cognitive dysfunction in patients with breast cancer.
Methods
Previously chemotherapy-naïve women about to receive adjuvant chemotherapy for breast cancer were randomized to receive 60 mg of EGB 761 or a matching placebo twice daily. The study agent was to begin before their second cycle of chemotherapy and to be taken throughout chemotherapy and 1 month beyond completion. The primary measure for cognitive function was the High Sensitivity Cognitive Screen (HSCS), with a secondary measure being the Trail Making Tests (TMT) A and B. Subjective assessment of cognitive function was evaluated by the cognitive subscale of the Perceived Health Scale (PHS) and the Profile of Mood States (POMS). Data were collected at baseline and at intervals throughout and after chemotherapy, up to 24 months after completion of adjuvant treatment. The primary statistical analysis included normalized area under the curve (AUC) comparisons of the HSCS, between the arms. Secondary analyses included evaluation of the other measures of cognition as well as correlational analyses between self-report and cognitive testing.
Results
One hundred and sixty-six women provided evaluable data. There were no significant differences in AUC up to 12 months on the HSCS between arms at the end of chemotherapy or at any other time point after adjuvant treatment. There were also no significant differences in TMT A or B at any data point. Perceived cognitive functions, as measured by the PHS and confusion/bewilderment subscale of the POMS, were not different between arms at the end of chemotherapy. There was also little correlation between self-reported cognition and cognitive testing. No differences were observed in toxicities per Common Terminology Criteria for Adverse Events (CTCAE) assessment between Ginkgo biloba and placebo throughout the study; however, after chemotherapy, the placebo group reported worse nausea (p=0.05).
Conclusion
This study did not provide any support for the notion that Ginkgo biloba, at a dose of 60 mg twice a day, can help prevent cognitive changes from chemotherapy. These analyses do provide data to further support the low associations between patients' self-report of cognition and cognitive performance, based on more formal testing.
Publication: The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase 3 clinical trial +
Background: Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a substantial problem for many cancer patients. Pursuant to promising appearing pilot data, the current study evaluated the use of vitamin E for the prevention of CIPN.
Methods: A phase III, randomized, double-blind, placebo-controlled study was conducted in patients undergoing therapy with neurotoxic chemotherapy, utilizing twice daily dosing of vitamin E (400 mg)/placebo. The primary endpoint was the incidence of grade 2+ sensory neuropathy (SN) toxicity (CTCAE v 3.0) in each treatment arm, analyzed by chi-square testing. Planned sample size was 100 patients per arm to provide 80% power to detect a difference in incidence of grade 2+ SN toxicity from 25% in the placebo group to 10% in the vitamin E group.
Results: Two-hundred seven patients were enrolled between December 1, 2006 and December 14, 2007, producing 189 evaluable cases for analysis. Cytotoxic agents included taxanes (109), cisplatin (8), carboplatin (2), oxaliplatin (50), or combination (20). There was no difference in the incidence of grade 2+ SN between the two arms (34%—vitamin E, 29%—placebo; P=0.43). There were no significant differences between treatment arms for time to onset of neuropathy (P=0.58), for chemotherapy dose reductions due to neuropathy (P=0.21), or for secondary endpoints derived from patient-reported neuropathy symptom assessments. The treatment was well tolerated overall.
Conclusions: Vitamin E did not appear to reduce the incidence of sensory neuropathy in the studied group of patients receiving neurotoxic chemotherapy. +
Publication: Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy +
It has been proposed that aloe cream could reduce the severity of skin toxicity from radiation therapy for breast cancer. The present 3-arm study compared control powder with double-blind aloe or placebo cream and found that the patients who had used dry powder skin care during radiation therapy had a lower severity of skin toxicity than that of the patients who had used either the placebo or aloe cream. We recommend a dry powder
regimen during radiation therapy to reduce the severity of skin toxicity. Background: The efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen. Materials and Methods: A total of 248 patients with breast cancer were randomized to powder, aloe cream,
or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary. Results: The aloe formulation
did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen. Conclusion: No evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy. +
Background & aims: The effect of lycopene-containing foods in prostate cancer development remainsundetermined. We tested whether a lycopene-rich tomato intervention could reduce the levels of prostate specific antigen (PSA) in prostate cancer patients.
Methods: Prior to their curative treatment, 79 patients with prostate cancer were randomized to a nutritional intervention with either 1) tomato products containing 30 mg lycopene per day; 2) tomato products plus selenium, omega-3 fatty acids, soy isoflavones, grape/pomegranate juice, and green/black tea (tomato-plus); or 3) control diet for 3 weeks.
Results: The main analysis, which included patients in all risk categories, did not reveal differences in changes of PSA-values between the intervention and control groups. Post-hoc, exploratory analyses within intermediate risk (n=41) patients based on tumor classification and Gleason score post-surgery, revealed that median PSA decreased significantly in the tomato group as compared to controls (-2.9% and +6.5% respectively, p=0.016). In separate post-hoc analyses, we observed that median PSA-values decreased by 1% in patients with the highest increases in plasma lycopene, selenium and C20:5 n-3 fatty
acid, compared to an 8.5% increase in the patients with the lowest increase in lycopene, selenium and C20:5 n-3 fatty acid (p=0.003). Also, PSA decreased in patients with the highest increase in lycopene alone (p=0.009).
Conclusions: Three week nutritional interventions with tomato-products alone or in combination with selenium and n-3 fatty acids lower PSA in patients with non-metastatic prostate cancer. Our observation suggests that the effect may depend on both aggressiveness of the disease and the blood levels of lycopene, selenium and omega-3 fatty acids. +
Publication: Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma: A Randomized Clinical Trial +
This randomized clinical trial compares topical sinecatechins ointment, 10%, vs. placebo in the treatment of superficial basal cell carcinoma. +
Publication: Tryptophan metabolites, pyridoxine (vitamin B6) and their influence on the recurrence rate of superficial bladder cancer. Results of a prospective, randomised phase III study performed by the EORTC GU Group +
This double-blind randomised phase III trial was designed to assess the effect of pyridoxine administration on the recurrence ofTa and T1 transitional cell tumours ofthe bladder. The trial accrued 291 patients and showed no significant difference between the pyridoxine and placebo treatment groups with respect to the time to first recurrence or the recurrence rate. Adjustment for the main prognostic factors, namely the recurrence rate prior to entry, the number of tumours at entry, the G grade and the levels of the tryptophan metabolites kynurenine plus acetyl kynurenine at entry do not change the overall conclusions. +
Publication: Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine +
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect of taxanes. AcetylL-carnitine (ALC) was unexpectedly found to increase CIPN in a randomized trial. We investigated the long-term patterns of CIPN among patients in this trial.
Methods: S0715 was a randomized, double-blind, multicenter trial comparing ALC (1000 mg three times a day) with placebo for 24 weeks in women undergoing adjuvant taxane-based chemotherapy for breast cancer. CIPN was measured by the 11-item neurotoxicity (NTX) component of the FACT-Taxane scale at weeks 12, 24, 36, 52, and 104. We examined NTX scores over two years using linear mixed models for longitudinal data. Individual time points were examined using linear regression. Regression analyses included stratification factors and the baseline score as covariates. All statistical tests were two sided.
Results: Four-hundred nine subjects were eligible for evaluation. Patients receiving ALC had a statistically significantly (P = .01) greater reduction in NTX scores (worse CIPN) of –1.39 points (95% confidence interval [CI] = –2.48 to –0.30) than the placebo group. These differences were particularly evident at weeks 24 (–1.68, 95% CI = –3.02 to –0.33), 36 (–1.37, 95% CI = –2.69 to –0.04), and 52 (–1.83, 95% CI = –3.35 to –0.32). At 104 weeks, 39.5% on the ALC arm and 34.4% on the placebo arm reported a five-point (10%) decrease from baseline. For both treatment groups, 104-week NTX scores were statistically significantly different compared with baseline (P < .001).
Conclusions: For both groups, NTX scores were reduced from baseline and remained persistently low. Twenty-four weeks of ALC therapy resulted in statistically significantly worse CIPN over two years. Understanding the mechanism of this persistent effect may inform prevention and treatment strategies. Until then, the potential efficacy and harms of commonly used supplements should be rigorously studied. +
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Publication: Use of alpha,25-dihydroxyvitamin D3 treatment to stimulate immune infiltration into head and neck squamous cell carcinoma +
Prior studies have shown that treatment of head and neck squamous cell carcinoma (HNSCC) patients with 1alpha,25-dihydroxyvitamin D(3) (1,25(OH)(2)D(3)) reduced intratumoral levels of immune inhibitory CD34(+) progenitor cells while increasing levels of mature progeny dendritic cells. This finding was extended to a pilot study to determine whether 1,25(OH)(2)D(3) treatment concurrently increases levels of intratumoral CD4(+) and CD8(+) T cells, increases intratumoral levels of immune cells expressing the early activation marker CD69, and prolongs time to HNSCC recurrence. The clinical trial comprised 16 patients with newly diagnosed HNSCC being untreated and 16 patients being treated with 1,25(OH)(2)D(3) during the 3-week interval between cancer diagnosis and surgical treatment. Immunologic effects of treatment were monitored by immunohistochemical analyses of surgically removed HNSCC. Clinical effectiveness of 1,25(OH)(2)D(3) treatment in this study was measured by the time to HNSCC recurrence. HNSCC tissues of patients who received treatment with 1,25(OH)(2)D(3) contained increased levels of CD4(+) cells and, more significantly, CD8(+) T cells. Also prominent was an increase in cells expressing the lymphoid activation marker CD69. Results of this pilot study suggest that patients treated with 1,25(OH)(2)D(3) had a lengthier time to tumor recurrence compared with patients who were not treated before surgery. +
Publication: Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial +
Patients with newly resected stage II melanoma (n = 104) were randomized to receive adjuvant vitamin D3 (100,000 IU every 50 days) or placebo for 3 years to investigate vitamin D3 protective effects on developing a recurrent disease. Median age at diagnosis was 50 years, and 43% of the patients were female. Median serum 25-hydroxy vitamin D (25OHD) level at baseline was 18 ng/mL, interquartile range (IQ) was 13–24 ng/mL, and 80% of the patients had insufficient vitamin D levels. We observed pronounced increases in 25OHD levels after 4 months in the active arm (median 32.9 ng/mL; IQ range 25.9–38.4) against placebo (median 19.05 ng/mL; IQ range 13.0–25.9), constantly rising during treatment. Remarkably, patients with low Breslow score (<3 mm) had a double increase in 25OHD levels from baseline, whereas patients with Breslow score ≥3 mm had a significantly lower increase over time. After 12 months, subjects with low 25OHD levels and Breslow score ≥3 mm had shorter disease-free survival (p = 0.02) compared to those with Breslow score <3 mm and/or high levels of 25OHD. Adjusting for age and treatment arm, the hazard ratio for relapse was 4.81 (95% CI: 1.44–16.09, p = 0.011). Despite the evidence of a role of 25OHD in melanoma prognosis, larger trials with vitamin D supplementation involving subjects with melanoma are needed. +