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- Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer + (''Overall OS:'' no significant difference … ''Overall OS:'' no significant difference between intervention and placebo group regarding hazard ratio</br>''a) mean age (SD):'' intervention group 69.7 (6.4) vs. placebo group 64.4 (8.8); p = 0.01</br>b) both smokers and non-smokers not significantly better in intervention arm</br>c) no significant difference in hazard ratio for low vs. high plasma beta-caroteneatio for low vs. high plasma beta-carotene)
- Brown et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized Trial + (''Overall:'' In the subgroup of 105 partic … ''Overall:''</br>In the subgroup of 105 participants randomization to high-dose vitamin D3 was associated with a lower risk of disease progression or death as compared with low-dose vitamin D3 [HR: 0.67; (95% CI: 0.42, 1.07)]; the magnitude of risk reduction was similar to that observed in the full analysis set of 139 participants as previously reported;</br></br></br>Change in body composition over the first 8 cycles of chemotherapy did not mediate the association between randomized arm and progression-free survivalndomized arm and progression-free survival)
- Ng et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial + (''Overall:'' No significant differences)
- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (''Overall:'' No significant differences)
- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (''Overall:'' No significant differences)
- Akiba et al. (2018): Vitamin D Supplementation and Survival of Patients with Non–small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial + (''Overall:'' No significant differences (p=0.63))
- Akiba et al. (2018): Vitamin D Supplementation and Survival of Patients with Non–small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial + (''Overall:'' No significant differences (p=0.64))
- Ng et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial + (''Overall:'' No significant differences; … ''Overall:''</br>No significant differences;</br></br>Supporting analysis: multivariable HR for progression-free survival or death was 0.64 (95% CI, 0-0.90; p=.02)</br></br>Subgroupanalysis: High-dose vitamin D<sub>3</sub> on progression-free survival appeared to be greater among patients with a lower body mass index (p=.04 for interaction), more metastatic sites (p=.02 for interaction), and KRAS wild-type tumors (p=.04 for interaction)</br></br>Post-Hoc-Analysis: Comparison between the both arms: ECOG performance status was statistically significant (p=.03); </br>No effects for adjustment by enrollment sites or tumor locations for adjustment by enrollment sites or tumor location)
- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (''Overall:'' Subgroupanalysis: low (<20 … ''Overall:''</br>Subgroupanalysis: low (<20 ng/mL (n=173)), middle (20-40 ng/mL (n=232)), or high (>40 ng/mL (n=5)) serum levels of 25(OH)D at baseline</br>* In middle-baseline-level subgroup, 5-year relapse-free survival significantly higher in intervention arm than in placebo arm (85% vs. 71%; HR for relapse or death, 0.46; 95% CI, 0.24-0.86; p=.02) </br>* In low-baseline-level subgroup no significant differences</br>* In high-baseline-level subgroup no further analyses because of small number of patients</br></br>* Overall survival was not significantly different between the arms in both the middle subgroup and the low subgroup</br></br></br>Post hoc analysis: </br>* Cumulative incidence of relapse was not significantly different</br>* In the subgroup with middle baseline levels of 25(OH)D, the cumulative incidence of relapse was significantly lower in the intervention arm than in the placebo arm (subdistribution HR, 0.44; 95% CI, 0.21-0.89; p=.02)</br>* No significant difference for the cumulative incidence of relapse in the low-baseline-level subgroup</br>* Age adjusted analysis: hazard of relapse or death was significantly less in intervention arm compared with the placebo arm, with an adjusted HR of 0.66 (95% CI, 0.43-0.99; p=.048) but hazard of death was not significantly different</br>* Analyses adjusted for stage I disease status did not show any significant differences</br>* No ignificant associations for gender, age groups, body many index, site of cancer, disease stage and adenocarcinoma vs. nonadenocarcinomae stage and adenocarcinoma vs. nonadenocarcinoma)
- Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer + (- Intervention group 20% vs. placebo group 10% - According to authors no significant differences (no p-value given))
- Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer + (- None in intervention group - Two in placebo group (1 case of tongue cancer and 1 of floor of mouth cancer) - No p-values reported)
- Del Giglio (2013): Purified Dry Extract of Paullinia cupana (Guarana) (PC-18) for Chemotherapy-Related Fatigue in Patients with Solid Tumors: An Early Discontinuation Study + (1 Patient: depression 1 Patient: dizziness)
- Ripamonti et al. (1998): A randomized, controlled clinical trial to evaluate the effects of zinc sulfate on cancer patients with taste alterations caused by head and neck irradiation + (1 month after radiotherapy: patients in th … 1 month after radiotherapy: patients in the intervention arm had quicker recovery of taste acuity than the those in the placebo arm (with the exception of the NaCl detection threshold), up to total recovery of taste acuity with respect to basal time and the NaCl recognition threshold, and even an improvement in the HCl recognition thresholdprovement in the HCl recognition threshold)
- Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization + (10-year disease-free survival intervention arm 80.1% vs. control arm 83.2%; not significant; p = 0.65)
- Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization + (10-year overall survival intervention arm 55.3% vs. control arm 42.7%; not significant; p = 0.09)
- Moslemi et al. (2014): Oral zinc sulphate and prevention of radiation-induced oropharyngealmucositis in patients with head and neck cancers: A double blind, randomized controlled clinical trial + (2 weeks after end of the treatment, difference between results of intervention and placebo arm were statistically significant (p < 0.05))
- Lin et al. (2006): Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study + (2 weeks after the completion of therapy, the conditions of mucositis seemed to have similar improvement in both arms)
- Lin et al. (2006): Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study + (2 weeks after the completion of therapy, the conditions of dermatitis seemed to have similar improvement in both arms)
- Jacot et al. (2016): Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study + (52 patients without vitamin D normalizatio … 52 patients without vitamin D normalization from the control arm switched to the intervention arm after 6 months: at 12 months, 44% of these patients (n = 23) showed vitamin D normalization, median 6- and 12–month vitamin D levels were 23.9 ng/ml (8.1–29.6) and 28.6 ng/ml (16.3–53.0) respectively (p < 0.001)ng/ml (16.3–53.0) respectively (p < 0.001))
- Fallahi et al. (2013): Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? + (6 months after Radiojodtherapy: Mean (SD; … 6 months after Radiojodtherapy:</br>Mean (SD; Range) for each:</br></br>Change in Vitamin E Arm:</br>No significant differences between from before to 6 months after radiojodtherapy.</br></br>Change in Placebo Arm:</br>Right submandibular gland:</br>MSP: before radiojodtherapy: 28.73 (14.59; 0.4–67.11); 6 months after: 24.53 (10.91; 4.46–45.05); p = 0.039, sign.</br>EF: before radiojodtherapy: 47.73 (16.65; 7.60–81.50); 6 months after: 43.02 (16.69; 15.18–76.32); p = 0.015, sign.</br></br>Left parotid gland :</br>EF: before radiojodtherapy: 58.14 (7.85; 44–73.67), 6 months after: 51.99 (21.12; 4.23–76.82); p = 0.035, sign.</br></br>Otherwise: not significant</br></br>--------------</br></br>Comparison Vitamin E (Vitamin E arm) vs. Placebo (placebo arm):</br>Mean (SD; Range) from before to 6 months after radiojodtherapy</br></br>Right parotid gland:</br>FUR: Vitamin E: 0.39 (0.97; –2.88-0.97); Placebo: 0.09 (0.47; –0.84-1.06); p = 0.04, sign; otherwise not significant.</br></br>Right submandibular gland:</br>No significant differences.</br></br>Left Parotid gland:</br>EF: Vitamin E: 0.43 (9.48; –15.16-23.57); Placebo: 11.15 (22.49; –13.7-60.9); p = 0.04, sign.; otherwise not significant.</br></br>Left submandibular gland:</br>No significant differences.</br></br>Number of Parotid glands with more than 15% decrease in EF:</br>Vitamin E: 3/38 (7.9%), Placebo: 9/34 (26.5%); p = 0.035, sign.), Placebo: 9/34 (26.5%); p = 0.035, sign.)
- Ertekin et al. (2004): Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study + (6 weeks after treatment, mucositis was found in 1 of the patients in the intervention compared with 10 patients in the placebo arm (Fisher’s exact chi-square test 16.2, p < 0.01))
- Marucci et al. (2017): 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 + (61 patients (58.6%) developed peak grade 3 … 61 patients (58.6%) developed peak grade 3 objective mucositis during treatment, with no difference between arms (p=0.665).</br></br>57 patients (54.8%) developed peak grade 3 functional mucositis during treatment with no differences between arms (p=0.442).</br></br></br>67 patients (64.4%) developed peak grade 3 dysphagia during treatment, with no differences between arms (p = 0.132).h no differences between arms (p = 0.132).)
- Halyard et al. (2007): 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) + (?)
- Lin et al. (2006): Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study + (?)
- Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck + (After 12 months: No significant differences between arms)
- Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck + (After 12 months: No significant differences between arms)
- Chan et al. (2011): Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer + (After 12 weeks mean difference: lycopene: 0.53 ng/ml, fish oil: 0.20 ng/ml, placebo: -0.46 ng/ml; p(lycopene vs. placebo)= 0.26, not significant; p(fish oil vs. placebo) = 0.39, not significant)
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (After 5 years: selenium arms not significantly different to placebo arm (p=0.32 and p=0.61) or to each other Subgroup of high-selenium arm with high selenium value at baseline shows higher PSA values than placebo arm (p=0.018))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 39.1 (12.1), pentoxyfillin + placebo: 32.4 (20.8), vitamin E + placebo: 37.1 (15.5); placebos: 32.9 (18.5))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 73.0 (7.2), pentoxyfillin + placebo: 48.6 (35.9), vitamin E + placebo: 52.8 (29.4); placebos: 50.8 (23.9))
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 60.2 (10.7), pentoxyfillin + placebo: 39.1 (37.4), vitamin E + placebo: 40.0 (32.0); placebos: 42.6 (17.4) ANOVA: ns., trend of a signif. interaction with vitamin E)
- Upadhyaya et al. (2017): Radioprotective effect of vitamin E on salivary glands after radioiodine therapy for differential thyroid cancer: A randomized-controlled trial + (After 6 months: Vitamin E 100mg: Increas … After 6 months: </br></br>Vitamin E 100mg: Increase EF right parotis (p < 0.01) and UI right submand. (p < 0.05)</br>Vitamin E 200mg: Increase UI right parotis, both Submand. (p < 0.01)</br>Vitamin E 300mg: Increase UF left parotis (p < 0.05) and right submand. (p < 0.01), increase UI in both submand. (p < 0.01)</br>Usual Care: Decreasel UF in both parotis (p < 0.01) </br>Rest: ns.</br></br>All arms compared:</br>UF: left submand.: p < 0.05</br>UI: right parotis: p < 0.05; both submand.: p < 0.01</br>ER: left parotis: p < 0.05otis: p < 0.05; both submand.: p < 0.01 ER: left parotis: p < 0.05)