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Ovarian, Colorectal, Lung (Non-Small Cell), Breast, Lymphoma (Hodgkins), Thyroid, Lung (Small Cell), Uterine Cervix, Multiple Myeloma, Lymphoma (Non-Hodgkins), and Leukemia

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Unique Dataset IDnci-data-391ClinicalTrial.gov IDNCT00459134
DownloadableNo
SponsorWake Forest University Health SciencesData ProviderNational Cancer InstituteTotal Study Enrolled Patients186RandomizationYesPubMed (PMID)26287032.0
Study PhaseN/ABlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Trial Summary and Conditions

RATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors. PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Determine whether an L-arginine-based nutritional supplement (ArginMax?) improves the quality of life and sexual function in female cancer survivors. Secondary: Compare quality of life of patients treated with ArginMax? vs placebo. Compare toxicity of these regimens in these patients. Describe the sexual function symptom clusters (if any) in these patients. OUTLINE: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), type of malignancy (pelvic vs nonpelvic), and ovarian functional status (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive an oral L-arginine-based nutritional supplement (ArginMax?) twice daily. Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Sexual function, quality of life, and toxicity are assessed at baseline and every 4 weeks for 12 weeks. PROJECTED ACCRUAL: A total of 186 patients will be accrued for this study.

Outcome Measures

Primary: Sexual Function [ Time Frame: 12 weeks ] Secondary: Quality of Life [ Time Frame: 12 weeks ]

ClinicalTrial.gov

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

NCI Description

This dataset contains all the data used in the publication cited above (PMID=26287032). Baseline demographic and clinical variables are provided for time = 0 (baseline visit). The primary outcome measures for the study are assessed at each time (0=baseline, 4=4 weeks, 8=8 weeks, and 12=12 weeks). Summary measures that are calculated across the participant?s time on study (e.g., worst toxicities and compliance) are recorded on the time = 99 rows. Note that these are measures determined over the entire study period, not a specific time. Notes: Missing data are denoted by a blank or a ?.? for each variable.

Available Downloads: NCT00459134-D1

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

Data Dictionary: NCT00459134-D1-Data-Dictionary.pdf

DATA: NCT00459134-D1-Dataset.csv

OTHER: README.pdf