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- 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 + (NI)
- Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer + (NI)
- Lyckholm et al. (2012): A randomized, placebo controlled trial of oral zinc for chemotherapy-related taste and smell disorders + (NI)
- 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 + (NI)
- 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 + (NI)
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (NI)
- Lin et al. (2008): Effects of zinc supplementation on clinical outcomes in patients receiving radiotherapy for head and neck cancers: a double-blinded randomized study + (NI)
- Khan et al. (2017): Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms in women with breast cancer receiving adjuvant letrozole. The VITAL trial + (NI)
- Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) + (NI)
- Mazdak et al. (2012): Vitamin E reduces superficial bladder cancer recurrence: A randomized controlled Trial + (NI)
- Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial + (NI)
- Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial + (NI)
- Johansson et al. (2021): Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial + (NI)
- Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients + (No ITT analysis specified, but no drop-out occured)
- Sahebjamee et al. (2015): Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial + (No drop-outs; chi-square test; t-tests; Mann-Whitney U-test; GEE test with correlation matrix AR (1) and an ordinal logistic model were performed to evaluate differences between mucositis grade changes during the 2-month treatment period.)
- 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 + (No information about possible drop-out)
- Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology + (No information about possible drop-out)
- Muecke et al. (2013): Impact of treatment planning target volumen (PTV) size on radiation induced diarrhoea following selenium supplementation in gynecologic radiation oncology-a subgroup analysis of a multicenter, phase III trial + (No information about possible drop-out)
- Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study + (No information provided on intent-to-treat analyses, but according to the tables all randomized patients appear to have been included in the analyses.)
- Lichtmann et al. (2018): Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain + (Number of participants evaluated in PP n=2 … Number of participants evaluated in PP n=291</br></br>For the primary efficacy endpoint, that is, percent improvement in average pain NRS score from baseline to end of treatment, the comparison was analyzed using the Wilcoxon rank-sum test. Estimates of the median difference between nabiximols and placebo, together with approximate 95% CI, were calculated using the Hodges-Lehmann approach, and P-values were used for the hierarchical gate-keeping procedure. Other sensitivity analyses for the primary efficacy endpoint included the Wilcoxon rank-sum test based on the PP analysis set, Van der Waerden test, and analysis of covariance with the corresponding baseline value as a covariate and treatment group as a factor, based on the ITT analysis set. Mixed-effect model repeat measurement was also applied with baseline NRS average pain score as a covariate, treatment group as a fixed factor, and the interaction terms for treatment-by-time and baseline-by-time included.</br></br>For the key secondary efficacy endpoints (average pain score, worst pain score, and sleep disruption score), analysis of covariance was applied, similar to the primary efficacy endpoint analysis. P-values from these analyses were used for the hierarchical gate-keeping procedure. The time course of the treatment effect on the key secondary endpoints was also evaluated in a similar fashion to the primary efficacy endpoint using model repeat measurement on the ITT analysis set. Analysis of variance was applied on the other secondary endpoints, including PGIC, SGIC, or PSQ, daily total/maintenance/breakthrough opioid dose, except NRS constipation score with ordinal logistic regression.</br></br>Subgroup analyses for region (U.S. and rest of the world (ROW)) were performed for the primary and key secondary efficacy endpoints using the ITT set at the 0.05 level, without formal adjustment for multiplicity.ithout formal adjustment for multiplicity.)
- Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer + (Occurrence, duration and severity of oral mucositis (WHO: grade 0-4, weekly check of oral status during radiotherapy, then monthly by doctor and an author); log rank analysis)
- Lian et al. (2014): Comparing the Effectiveness of Green Tea versus Topical Metronidazole Powder in Malodorous Control of Fungating Malignant Wounds in a Controlled Randomised Study + (One patient in the green tea group did not … One patient in the green tea group did not complete the seven days of treatment as she died of advanced cancer on day 5, the malodorous scores for day 5 to day 7 were conservatively assumed as per scored on day 4.</br>Frequencies and percentages were calculated for categorical variables; Descriptive statistics were calculated for continuous variables; Wilcoxon ranksum test was used for statistical analysis to compare the malodorous scores between the two armsthe malodorous scores between the two arms)
- Dyer et al. (2013): Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population? + (One-tailed independent samples t-test)
- Arslan et al. (2015): Oral Intake of Ginger for Chemotherapy-Induced Nausea and Vomiting Among Women With Breast Cancer + (Only included participants (n=60) reported, NI regarding number of randomized patients)
- Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial + (Only participants who have received both i … Only participants who have received both interventions have been included in the efficacy analyses. Data on safety were sourced from the safety population (all participants who received ≥1 dose of study drug). The primary analysis was a comparison of the proportion of participants with complete response between the two treatment arms during two overall phases of treatment (0-120 h) of cycles A and B, using McNemar’s test to account for the within-patient correlation. Continuous outcomes were analysed with a linear model, and accounted for the correlation within a participant. All tests used a two-sided significance level of 10%. Secondary analyses have not been adjusted for multiple comparisons.ot been adjusted for multiple comparisons.)
- Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer + (Only patients completing 12 wk of treatment were considered evaluable for objective response using WHO criteria; ITT Analysis for endpoints overall survival and progression-free survival)
- 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 + (Paired t-test)
- Hodgson et al. (2012): Reflexology versus Swedish Massage to Reduce Physiologic Stress and Pain and Improve Mood in Nursing Home Residents with Cancer: A Pilot Trial. + (Paired t-test)
- Mondal et al. (2014): Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy + (Patients receiving < 4 cycles of paclitaxel or any dose curtailments were excluded from the analysis)
- Kottschade et al. (2011): The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase 3 clinical trial + (Patients who received at least one dose of assigned therapy were defined as evaluable for the primary endpoint.)
- Nguyen et al. (2012): Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities + (Per-protocol evaluation of the endpoints; … Per-protocol evaluation of the endpoints; Intention-to-treat evaluation of side effects; 2-sided Wilcoxon rank-sum test: test whether the change in each of the endpoints differed by the intervention arm, because the distributions for some of the endpoints were not symmetrical; percentage of patients with positive or negative changes for each of the endpoints was compared between the intervention arm using a Fisher exact test of proportions at a 2-sided 0.05 level of significance; secondary analyses were not corrected for multiple comparisons, but the results were interpreted cautiously, given the multiple markers being explored.given the multiple markers being explored.)
- Beer et al. (2007): 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 + (Primary analysis for efficacy was on the intention to treat population and toxicity was evaluated in the as-treated population. These two populations were identical.)
- Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers + (Primary endpoints: all patients were analysed (ITT), secondary endpoints: just 93 patients were analysed (PP))
- Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies + (Procedure Part A: all received Sativex® fo … Procedure</br>Part A: all received Sativex® for 10 days, then 4 days therapy at adjusted dose; patients who showed an improvement of at least 15% for pain (NRS) entered Part B: randomized in A or B with intervention for 5 weeks, follow-up 2 weeks later</br></br>Discussed is part B of the study.s later Discussed is part B of the study.)
- Konmun et al. (2017): 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 + (Repeated ANOVA, paired t test/Wilcoxon signed ranks test, unpaired t test/nonparametric Mann–Whitney U test)
- Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Repeated measures analyses of variance (AN … Repeated measures analyses of variance (ANOVA), estimated with a linear mixed model, enable us to test the effect of time and treatment on continuous outcomes, while a generalized linear mixed model is used as a logistic regression for dichotomous outcomes. The P-values that are presented are for the interaction term of these models. All the analyses were also carried out while adjusting for site, treatment, and tumor size.sting for site, treatment, and tumor size.)
- Freedland et al. (2020): 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) + (Results are calculated and analyzed as the … Results are calculated and analyzed as the mean of log-transformed PSADT, but back transformed for presentation and interpretation. An amendment to the study protocol was added to conduct a two-step interim analysis to test for efficacy and/or futility after 44 of the targeted 60 patients had completed the study. First, efficacy was assessed by comparing the mean PSADT between arms using a two-sided, two-sample t-test at alpha level of 0.01. Next, given a non-significant efficacy test, treatment futility was assessed by calculating the conditional power of the t-test given the interim data with conditional power <0.2 determining futility.nditional power <0.2 determining futility.)
- Argyriou et al. (2006): A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results + (Separate intention-to-treat (ITT) and all those who completed the study (PP) analysis for primary endpoint, secondary endpoints only PP analysis)
- Argyriou et al. (2006): Preventing Paclitaxel-Induced Peripheral neuropathy: A Phase 2 Trial of Vitamin E Supplementation + (Separate intention-to-treat (ITT) and all those who completed the study (PP) analysis for primary endpoint, secondary endpoints only PP analysis)
- Khodabakhshi et al. (2019): Feasibility, Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study + (Statistical analysis was carried out accor … Statistical analysis was carried out according to the intention to treat protocol. Continuous variables were tested for normal distribution by the Kolmogorov-Smirnov test, then reported as mean (SD) or median as appropriate. Student t-test or Mann–Whitney U test was used to compare continuous variables between groups. Categorical data were summarized as percentages and analyzed with the chi-square test. A repeated measures ANOVA was used to evaluate differences at baseline, middle, and endpoints in time-dependent variables within patient groups.</br></br>ITT analysis specified, but unclear because demographic information from only 60 patientsographic information from only 60 patients)
- Togni et al. (2015): 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 + (Student´s t and Mann-Whitney U test for arms comparison)
- Yekta et al. (2012): Ginger as a miracle against chemotherapy-induced vomiting + (T-test and Fisher´s exact test for comparing the 2 arms For examine differences in the profile of the diseases: Kruskal-Wallis and Chi-square test were applied)
- Dos Santos Martins (2016): Placebo-Controlled, Double-Blind, Randomized Study of a Dry Guarana Extract in Patients with Head and Neck Tumors Undergoing Chemoradiotherapy: Effects on Fatigue and Quality of Life + (T-test, ANOVA/Wilcoxon test)
- Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia + (The analysis was performed on an intent-to … The analysis was performed on an intent-to treat basis. An interim analysis was planned every 100 randomized patients to test the efficacy (primary efficacy endpoints) and the toxicity of the different arms according to the following “early stopping rules”: the arm(s) in which the efficacy values were significantly lower (p .05), by a t-test for changes, than in the other arms would be stopped. Likewise wise, the arm(s) in which grade 3 or 4 toxicity values were significantly higher by a t-test for changes, than in the other arms would be stopped. </br>A very low level for the significance of p-values (p .001) was chosen considering that there are 10 possible pairs of between-arm comparisons and three endpoints, implying 30 possible candidate analyses; p-values are reported including Bonferroni’s corrections for multiple comparisons.ni’s corrections for multiple comparisons.)
- Puri et al. (2010): Lycopene in treatment of high-grade gliomas: A pilot study + (The data was analyzed using SPSS Software v10.0 (SPSS corporation Chicago IL) by applying Student’s t-test, ANOVA F test, Chi-square test and Karl Pearson Correlation Coefficient.)
- Mahmoodnia et al. (2017): Ameliorative effect of lycopene effect on cisplatin-induced nephropathy in patients + (The data were analyzed by SPSS 20 software … The data were analyzed by SPSS 20 software. The quantitative variables were expressed as mean (standard deviation) or median (interquartile range) and qualitative variables as number (%). To compare quantitative variables, repeated measures analysis of variance (ANOVA) was used and to compare qualitative variables, chi-square compare qualitative variables, chi-square)
- Yap et al. (2017): Predictors of hand-foot syndrome and pyridoxine for prevention of capecitabine-induced hand-foot syndrome: a randomized clinical trial + (The incidence of grade 2 or higher HFS was … The incidence of grade 2 or higher HFS was compared using a χ2 test; time to onset was estimated using the Kaplan-Meier method and compared using a log-rank test, and QoL was analyzed using ANOVA for the EQ-5D OHS and χ2</br>tests for each of the 5 dimensions of the EQ descriptive system.</br>Logistic regression was used to estimate the odds of HFS (grade ≥2 vs <2) with respect to clinical characteristics. The exact procedure was used when quasiseparation was detected. All covariates were included in multivariate analysis with a stepwise selection process using significance levels of 0.1. Interaction between treatment and covariates suggested by the stepwise procedure was explored. Alternative models were assessed in terms of discrimination and calibration respectively using the c-index and the Akaike Information criterion (AIC).x and the Akaike Information criterion (AIC).)
- Paur et al. (2017): Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA + (The number of samples analyzed per endpoin … The number of samples analyzed per endpoint differs slightly since some samples were not available for analysis.</br>Pre-intervention values and PSA changes during the intervention were not normally distributed and were thus tested statistically using Kruskal Wallis test and Mann-Whitney test. Fishere-Freemane-Halton test was used to identify statistical differences in categorical data and contingency tables. For tests of correlation, Spearman's Correlation Coefficient was calculated.'s Correlation Coefficient was calculated.)
- Lin et al. (2010): 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 specific analysis method is not stated in the study, however, according to the authors, all included patients in the subgroup analysis were evaluated at the end of the study)
- Najafizade et al. (2013): Preventive effects of zinc sulfate on taste alterations in patients under irradiation for head and neck cancers: A randomized placebo-controlled trial + (The specific analysis method is not stated in the study, however, according to the authors, all included patients were evaluated at the end of the study.)
- Watanabe et al. (2010): Polaprezinc prevents oral mucositis associated with radiochemotherapy in patients with head and neck cancer + (The specific analysis method is not stated in the study, however, according to the authors, all included patients were evaluated at the end of the study.)
- Nasser et al. (2017): Vitamin D ointment for prevention of radiation dermatitis in breast cancer patients + (The specific analysis method is not stated in the study, however, according to the authors, all included patients were evaluated at the end of the study.)