Property:Specifications on analyses
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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 +
All analyses adhered to the modified intention-to-treat principle. +
Büntzel et al. (2010): Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patients +
ITT-analysis not specified, but no drop-out occured +
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 +
C
Campos et al. (2011): Guarana (Paullinia cupana) Improves Fatigue in Breast Cancer Patients Undergoing Systemic Chemotherapy +
3 weeks of receiving placebo/intervention, 1 week washout, 3 weeks of receiving intervention/placebo
Consort diagram shows, that drop-out was excluded from final analysis, even though an ITT-analysis was mentioned in the method section +
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 +
Chan et al. (2011): Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer +
Baseline characteristics were compared among the three study arms using analysis of variance methods (ANOVA) for continuous variables and chi-square tests for categorical variables. To test the two primary hypotheses to detect a decrease in the mean changes in IGF-1 (or COX-2) gene expression between the lycopene (or fish oil) and placebo
arms a t statistic was used with significance set at a probability <0.025 to adjust for the two comparisons. The same method was used to test for a decrease in IGF-1R with the
lycopene supplement without any adjustment for multiple testing. Fisher’s exact test to determine whether a greater proportion of patients on the supplement arm achieved at least a 2-fold decrease in IGF-1 (or COX-2) expression when compared with the placebo group was used.
An exploratory analyses was conducted using 2-way ANOVA methods to investigate the change in gene expression (pre to post-intervention) in DCT on the log2 scale due to the study arm (supplement or placebo), baseline tomato/fish intake (high or low) or their interaction. If statistical significance was observed, the Newman-Keuls post hoc test was used to identify which subsets were significantly different. Mean baseline and change from baseline results were presented on the log2 scale. +
Chung et al. (2016): Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer +
According to authors ITT analysis but loss to follow-up (n=7) not included in analyses +
Cohen et al. (2018): Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial +
Analysis of covariance (ANCOVA) was used to assess between-group differences. Baseline values, chemotherapy status, and/or change in fat mass were used as covariates where appropriate. To assess differences in perceived energy between diet groups, sub-group analyses were conducted on the basis of chemotherapy status due to the prevalence of chemotherapy-related fatigue. Paired t-tests were used to assess within-group differences. Pearson correlation analyses were used to estimate associations between questionnaire results and serum β-hydroxybutyrate concentration, a biomarker of circulating ketones.
The statistical analysis plan included an investigation for outliers, and the final analyses excluded them in order to lessen the influence of extreme observations on the overall results. One outlier (>3 standard deviations above the mean) was excluded from food craving analyses involving starches and high-fat foods. In addition, two participants in the KD group only partially completed the SF-12 at the follow-up visit; two participants in the KD group also did not complete all items on the VAS. Accordingly, these participants’ responses have been excluded from the corresponding analyses. +
Crew et al. (2012): Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer +
Time-to-event continual reassessment method (TITE-CRM) +
Cruciani et al. (2009): L-Carnitine Supplementation in Patients with Advanced Cancer and Carnitine Deficiency: A Double-Blind, Placebo-Controlled Study +
ITT-Analyse n=29
Per Protocol Analyse n= 27
An exploratory analysis was performed in which the data (all 17 patients who started on L-carnitine plus 10 patients who started on placebo, inkluding two protocol violators) was supplemented by the scores recorded at the end of the open-label phase. The pattern mixture analysis used three measurements over time and accounted for missing data. +
Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial +
Included were n=376, but n=43 patients left study before start of intervention. +
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 (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. +
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Da Costa et al. (2009): Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized Study +
ANOVA +
Dale et al. (2001): Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects +
Unclear when the two attritions took place, as according to the tables all were included in the analysis. +
Dardano et al. (2012): The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131 +
ITT not specified, but no drop-out 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 +
Paired t-test +
Delanian et al. (2003): Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis +
NA +
Dias et al. (2015): The chemopreventive effect of Ginkgo biloba extract 761 against cisplatin ototoxicity: a pilot study +
ITT not specified, but no drop-out reported. +
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 +
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 +