Clinical Trials Directory

Trials / Completed

CompletedNCT00459134

L-Arginine Supplements in Treating Women Who Are Cancer Survivors

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
186 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTArginMaxGiven orally
DIETARY_SUPPLEMENTPlaceboGiven orally

Timeline

Start date
2007-05-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2007-04-11
Last updated
2021-09-28
Results posted
2015-01-19

Locations

25 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00459134. Inclusion in this directory is not an endorsement.