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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

Unique Dataset IDnci-data-404ClinicalTrial.gov IDNCT00081250
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients300RandomizationYesPubMed (PMID)28475678.0
Study PhaseN/ABlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypeOther, PlaceboDataset TypeOther

Clinical Trial Title

Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

Trial Summary and Conditions

RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer. PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.

Data Summary

See Data Dictionary.

Study Objectives

Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia. Determine the effect of these regimens on quality of life in these patients. Compare the toxic effects of these regimens in these patients. Compare survival rates of patients treated with these regimens.

Outcome Measures

Primary: Percentage of patients who gain weight over 1 month; Secondary: Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month; Percentage of patients who manifest stability in appetite; Overall survival; Incidence of treatment-related toxicity; Quality of life.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

Dataset NCT00081250-D1-Dataset.csv (qol) is one of 2 datasets associated with PubMed ID 28475678. This dataset contains information that will allow you to reproduce the primary analysis as well as other quality of life analyses.

Available Downloads: NCT00081250-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00081250-D1-Data-Dictionary_1.pdf

DATA: NCT00081250-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00081250-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00081250-D2-Data-Dictionary_2.pdf

DATA: NCT00081250-D2-Dataset_2.csv

OTHER: README.pdf