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- Montazeri et al. (2013): Effect of Herbal Therapy to Intensity Chemotherapy-Induced Nausea and Vomiting in Cancer Patients + (Kolmogorov-Smirnov Test)
- Shokri et al. (2017): Comparison of the Complications of Platinum-Based Adjuvant Chemotherapy With and Without Ginger in a Pilot Study on Ovarian Cancer Patients + (Kolmogorov-Smirnov test, T-test)
- Zick et al. (2008): Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Kruskal–Wallis statistics for continuous variables and Pearson’s chi-square and Fisher exact tests, as appropriate, for categorical variables. Cochran Mantel–Haenszel tests between treatment arms.)
- Bossi et al. (2017): A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin + (Logistic regression was used to estimate odds ratios for the incidence of nausea; ANOVA used to investigate differences in mean delayed, inter-cycle and anticipatory nausea between treatment arms and compliance to treatment.)
- Bairati et al. (2005): A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients + (Main analyses conducted in two ways: 1) a … Main analyses conducted in two ways: </br>1) among all participants (any supplementation)</br>2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E)</br></br>Analyses were performed by partitioning the time (after visual check of proportionality assumption of the models): </br>1) from entry until 3.5 years after randomization</br>2) beyond 3.5 years after randomization</br></br>4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses planned but were included in the analyses)
- Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients + (Main analyses conducted in two ways: 1) a … Main analyses conducted in two ways: </br>1) among all participants (any supplementation)</br>2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E)</br></br>4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses planned but were included in the analyses)
- Bairati et al. (2006): Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients + (Main analyses conducted in two ways: 1) a … Main analyses conducted in two ways: </br>1) among all participants (any supplementation)</br>2) separately for the first 156 participants (combined intake of beta-carotene and Vitamin E) and for the 384 patients subsequently enrolled (only Vitamin E)</br></br>4 patients (1 in intervention arm, 3 in placebo arm) did not complete their radiation therapy as planned but were included in the analyses planned but were included in the analyses)
- Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (Mann-Whitney U test)
- Raei et al. (2013): Effect of herbal therapy to intensity chemotherapy-induced nausea and vomiting in cancer patients + (Mann-Whitney U test)
- Fahimi et al. (2011): Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens + (McNemar and the Wilcoxon Signed Rank tests were used)
- Stendell-Hollis et al. (2010): Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors + (Measures of central tendency were computed … Measures of central tendency were computed and frequencies and distributions produced for demographic and clinical characteristics of the study participants and checked for missing values, normalcy and outliers, where appropriate, using the Shapiro–Wilk statistic for the normality test and pearson’s chi-square test for skewness and kurtosis.chi-square test for skewness and kurtosis.)
- Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (Missing data for the efficacy endpoints we … Missing data for the efficacy endpoints were imputed using the last observation carry forward (LOCF) method.</br></br>The proportions of responders were compared between the treatments using logistic regression, with region (North America/Rest of the World) and treatment used as factors. </br></br>The cumulative response to treatment was shown by plotting cumulative response rates against increasing thresholds for response, ie, percentage changes from baseline in the mean 11-point NRS pain score that defined a response. The cumulative response curves for each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median also were performed.</br></br>The analysis of all the secondary efficacy assessments was considered supportive and no formal adjustments for multiple comparisons were made. The change in mean pain NRS scores, BPI-SF, sleep disruption NRS, PAC-QoL questionnaire, and MADRS were all analyzed using analysis of covariance (ANCOVA), with the baseline value as a covariate and region and treatment group as factors. An analysis also was performed on the mean pain NRS scores to assess the time course of the treatment effect using repeated measure analysis. Additionally, the difference in time required to establish baseline was investigated as a possible moderator of treatment effect by using the number of days until the patient became eligible for randomization and total number of days in the baseline period as covariates in the analysis of change in the mean daily NRS score for</br>average pain.the mean daily NRS score for average pain.)
- Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597 + (NA)
- Büntzel et al. (2010): Selenium Substitution During Radiotherapy of Solid Tumours - Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer Patients + (NA)
- Afonseca et al. (2013): Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: A pilot randomized clinical trial + (NA)
- Azizi et al. (2015): Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis + (NA)
- Barton et al. (1998): Prospective evaluation of vitamin E for hot flashes in breast cancer survivors + (NA)
- Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis + (NA)
- Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial + (NA)
- Pace et al. (2003): Neuroprotective Effect of Vitamin E Supplementation in Patient Treated With Cisplatin Chemotherapy + (NA)
- Pace et al. (2010): Vitamin E neuroprotection for cisplatin neuropathy + (NA)
- Salehi et al. (2015): Effect of Vitamin E on Oxaliplatin-induced Peripheral neuropathy Prevention: A Randomized Controlled Trial + (NA)
- Villani et al. (2016): Vitamin E neuroprotection against cisplatin ototoxicity: Preliminary results from a randomized, placebo-controlled trial + (NA)
- Barton et al. (2013): The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9 + (NA)
- Hejazi et al. (2013): A pilot clinical trial of radioprotective effects of curcumin supplementation in patients with prostate cancer + (NA)
- Hejazi et al. (2016): Effect of Curcumin Supplementation During Radiotherapy on Oxidative Status of Patients with Prostate Cancer: A Double Blinded, Randomized, Placebo-Controlled Study + (NA)
- Rao et al. (2014): The Indian Spice Turmeric Delays and Mitigates Radiation-Induced Oral Mucositis in Patients Undergoing Treatment for Head and Neck Cancer: An Investigational Study + (NA)
- Ryan et al. (2013): Curcumin for radiation dermatitis: a randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patients + (NA)
- Cavallini et al. (2005): Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy + (NA)
- Hershman et al. (2013): Randomized Double-Blind Placebo-Controlled Trial of Acetyl-L-Carnitine for the Prevention of Taxane-Induced Neuropathy in Women Undergoing Adjuvant Breast Cancer Therapy + (NA)
- Hershman et al. (2018): Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine + (NA)
- Raoufinejad et al. (2019): Oral calcitriol in hematopoietic recovery and survival after autologous stem cell transplantation: a randomized clinical trial + (NA)
- Rastelli et al. (2011): Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial + (NA)
- Ertekin et al. (2004): Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study + (NI)
- Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial + (NI)
- 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) + (NI)
- Johansson et al. (2021): Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial + (NI)
- Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer + (NI)
- Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial + (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)
- 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)
- 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)
- 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)
- Lyckholm et al. (2012): A randomized, placebo controlled trial of oral zinc for chemotherapy-related taste and smell disorders + (NI)
- Mazdak et al. (2012): Vitamin E reduces superficial bladder cancer recurrence: A randomized controlled Trial + (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)
- Shapiro et al. (2016): Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) + (NI)
- Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (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)
- 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)
- 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)
- 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.)