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- Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (All patients who underwent randomization w … All patients who underwent randomization were included in the analysis;</br>Relapse- and death-related outcomes were assessed according to randomization arm whether or not supplements were taken, whereas adverse events were assessed only in patients who continued to take the supplements (per protocol)ued to take the supplements (per protocol))
- 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 + (All randomized patients were analyzed for efficacy, and 182 patients (93%) were evaluable for toxicity.)
- Uthaipaisanwong et al. (2020): Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled study + (All statistical analyses were performed us … All statistical analyses were performed using STATA version 15.1. P values less than 0.05 were considered significant. Demographic data of all participants were analyzed by using mean, 95%CI, and percentage.</br>Nausea score from day 1 to day 5 was showed in mean, and analysis of variance (ANOVA) for a 2 × 2 crossover study was analyzed comparing treatment, sequence, and period effect.</br>Nausea grading for each day was compared using proportion f grading between treatment after adjusted sequence and period by using random-effects ordered logistic regression.</br>Vomiting and side effects were analyzed by comparing percentages between groups using random-effects logistic regression. using random-effects logistic regression.)
- Wyatt et al. (2017): A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment + (All statistical tests were two sided.)
- 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 t … 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.</br>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.een excluded from the corresponding analyses.)
- Stephenson et al. (2017): Partner-delivered reflexology: Effects on cancer pain and anxiety. + (Arms were compared with t tests and chi-square tests)
- Chan et al. (2011): Nutritional supplements, COX-2 and IGF-1 expression in men on active surveillance for prostate cancer + (Baseline characteristics were compared amo … 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</br>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</br>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.</br>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.ine results were presented on the log2 scale.)
- Li et al. (2018): Efficacy of Ginger in Ameliorating Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Among Patients With Lung Cancer Receiving Cisplatin-Based Regimens: A Randomized Controlled Trial + (Baseline characteristics, QoL, and severit … Baseline characteristics, QoL, and severity of acute and delayed nausea and vomiting were compared between the 2 groups using independent samples t/nonparametric tests for continuous variables and Pearson’s χ2/Fisher’s exact tests for categorical variables.</br>Incidence of acute and delayed nausea and vomiting was calculated as a binary variable (“yes” if participants had nausea or vomiting or “no” if participants had no nausea or vomiting) and was compared with a Pearson χ2 test.</br>Two-tailed tests with a significance level of .05 were used for all analyses.e level of .05 were used for all analyses.)
- Panahi et al. (2012): Effect of Ginger on Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot, Randomized, Open-Label Clinical Trial + (Between-arm (ginger vs control) comparisons were performed using independent-samples t test (for quantitative variables) or χ2 and Fisher’s exact test (for categorical variables))
- Uysal et al. (2016): Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial + (Chi square test)
- Ansari et al. (2016): Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin- Based Chemotherapy + (Chi- square test, independent T-test and Mann-Whitney test)
- Sontakke et al. (2003): Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study + (Chi-square test)
- Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer + (Chi-square test)
- Su et al. (2004): Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms + (Chi-square tests; Kaplan-Meier analyses; Cox proportional hazard models)
- Sanaati et al. (2016): Effect of Ginger and Chamomile on Nausea and Vomiting Caused by Chemotherapy in Iranian Women with Breast Cancer + (Chi-squared test, inferential statistics of the linear logarithm model with Poison and paired t-test function)
- Henning et al. (2015): Randomized Clinical Trial of Brewed Green and Black Tea in Men With Prostate Cancer Prior to Prostatectomy + (Comparisons of baseline clinical and demog … Comparisons of baseline clinical and demographic variables between green tea arm, black tea arm and water arm was conducted using the ANOVA or Kruskal–Wallis tests for continuous variables and Fisher’s exact test or chisquare tests for categorical variables.</br>If a statistically significant overall group effect was found, follow-up analysis was performed using pairwise t-tests or the Mann Whitney U tests to investigate which pairs of groups were significantly different.rs of groups were significantly different.)
- Dörr et al. (2007): Efficacy of Wobe-Mugos E for Reduction of Oral Mucositis after Radiotherapy + (Data analyses were performed in three pati … Data analyses were performed in three patient populations:</br>Full analysis set (FAS) population: n=61; 8 drop-outs; FAS population represents the</br>intent-to-treat population with data available for > 2 weeks of treatment</br>Per protocol (PP) population: n=55 (29 enzyme-arm, 26 placebo-arm); FAS population exclusive of patients with major protocol deviations (termination of radiotherapy before week 5 or significant treatment interruptions > 1 week)</br>Dresden (DD) population: n=46 (23 enzyme-arm, 23 placebo-arm) from Dresden from the PP population were analyzed separately from the PP population were analyzed separately)
- Zalat et al. (2020): Evaluation of the cardioprotective effects of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy + (Data are expressed as the mean value (± st … Data are expressed as the mean value (± standard deviation). One-way analysis of variance test (one-way ANOVA) followed by LSD post hoc test was used to assess any significant difference between the three groups. Paired t-test was used to assess any significant difference within each group at baseline and after chemotherapy. All probability values presented were two-tailed and p ≤ 0.05 was considered statistically significant. was considered statistically significant.)
- Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy + (Data of 70 patients were availible.)
- Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial + (Evaluated ITT n=292, PP n=259; Sensitivity analysis n=216)
- Van Zandwijk et al. (2000): EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer + (Event-free survival, time to second primar … Event-free survival, time to second primary tumor, and survival curves were constructed by the Kaplan–Meier technique and were compared by the log-rank test. The interaction between the effects of N-acetylcysteine and those of retinyl palmitate was tested with a proportional hazards model. Also, analyses of four arms were performed.lso, analyses of four arms were performed.)
- 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 + (Exploratory analysis, 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.)
- Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain + (For the two coprimary efficacy variables ( … For the two coprimary efficacy variables (NRS pain score and use of break-through medication), the Hochberg method was used to test the global hypothesis for a treatment effect on pain.</br>The daily pain NRS score was the mean of the three daily assessments. The change in mean NRS pain score from baseline (all days in run-in period) to the end of treatment (last three days on treatment) was analyzed using analysis of covariance (ANCOVA), with baseline pain as a covariate and grouped study center and treatment as factors. The proportions of responders (patients with ≥30% improvement from baseline to end of study NRS pain score) were compared between treatments. Use of breakthrough medication (number of days of use during last three days on treatment) was analyzed using logistic regression with a cumulative logit model. In addition, the change from baseline in mean number of doses of escape medication was analyzed using ANCOVA.cape medication was analyzed using ANCOVA.)
- Tsay et al. (2008): Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer. + (Generalized estimation equations (GEE))
- Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial + (ITT Analysis planned, but no results of it … ITT Analysis planned, but no results of it reported. </br></br>Sample size calculation was based on previous studies investigating the effect of L-Carnitine on inflammatory markers, with TNFα level differences as the primary endpoint, and resulted in a recruitment goal of 90 patients (45 per treatment arm) for a statistical power of 90% with an error probability of <5%. After a prescheduled interim analysis for sample size recalculation of 72 blinded datasets showed a wide variation of the standard errors for inflammatory markers, a recruitment of 554 patients (277 per group) would have been necessary. Since this goal was unattainable, the study was closed after enrolment of 72 patients and the data were unblinded for statistical analysis.data were unblinded for statistical analysis.)
- Toma et al. (2003): β-carotene supplementation in patients radically treated for stage I-II head and neck cancer: Results of a randomized trial + (ITT analysis for all 3 outcomes strictly overlapped with secondary analysis (PP), therefore only ITT analysis presented by authors)
- Okabayashi et al. (2020): L-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients + (ITT analysis not specified, but no drop-out occured.)
- Fallahi et al. (2013): Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? + (ITT not explicitly stated, but no drop-out occured.)
- 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.)
- 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.)
- Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation + (ITT not specified, but no drop-out reported.)
- Koyama et al. (2017): Intravenous Carnitine Administration in Addition to Parenteral Nutrition With Lipid Emulsion May Decrease the Inflammatory Reaction in Postoperative Surgical Patients + (ITT not specified, but no drop-out reported.)
- Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer + (ITT not specified, but no drop-out reported.)
- Shamsaei et al. (2017): The Vitamin E Preventive Effect on Taxol-Induced Neuropathy Among Patients With Breast Cancer: A Randomized Clinical Trial + (ITT not specified, but no drop-out reported.)
- Upadhyaya et al. (2017): Radioprotective effect of vitamin E on salivary glands after radioiodine therapy for differential thyroid cancer: A randomized-controlled trial + (ITT not specified, but no drop-out reported.)
- 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= 2 … ITT-Analyse n=29</br>Per Protocol Analyse n= 27</br></br>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. over time and accounted for missing data.)
- Ota et al. (2014): The effect of pyridoxine for prevention of hand-foot-syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine: A randomized study + (ITT-analysis not specified, but no drop-ou … ITT-analysis not specified, but no drop-out occured.</br></br>The frequency, severity, clinical course, and consequences of HFS were determined by descriptive methods. Between-group differences were assessed using χ2 test for categorical variables. Inverted Kaplan-Meier curves were constructed to determine the relationship between cumulative dose of capecitabine and occurence of HFS, with differences assessed by the log-rank test.differences assessed by the log-rank test.)
- Braik et al. (2014): Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy + (ITT-analysis not specified, but no drop-ou … ITT-analysis not specified, but no drop-out occured.</br></br>The number of patients developing any grade of HFS in both study arms was obtained. The percentage of HFS in both arms was compared. In order to determine whether the diference between groups was signifcant, the number of patients receiving capecitabine, with and without HFS, was obtained, and the P value was determined through chi-square and Fisher exact calculation.h chi-square and Fisher exact calculation.)
- 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)
- 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.)
- Sun et al. (2016): A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy + (Independent sample t-tests or Wilcoxon tes … Independent sample t-tests or Wilcoxon tests were used to compare continuous variables between groups, and paired t-test or Wilcoxon tests were used for comparison within groups. For the categorical variable analysis, a χ<sup>2</sup> test or exact test were used for comparisons between groups. The Cochran-Mantel-Haenszel-χ2 test was used to analyze ordinal categorical data. Data were presented as the mean±standard deviation. P<0.05 was considered to indicate a significantly significant result.onsidered to indicate a significantly significant result.)
- Arbabi-kalati et al. (2012): Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: A double-blind randomized clinical trial + (Information is missing about how many patients were measured to the different time points)
- Akiba et al. (2018): Vitamin D Supplementation and Survival of Patients with Non–small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial + (Kaplan–Meier survival curves were drawn and compared using the log-rank test in an intention-to-treat analysis)
- 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)