L-Arginine Supplements in Treating Women Who Are Cancer Survivors

Not Applicable

Completed

Conditions: Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Sexual Dysfunction

Interventions: Dietary Supplement: ArginMax
Dietary Supplement: Placebo

Registration Number: NCT00459134

Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I: ArginMax	ArginMax	ArginMax® 3 pills twice daily
Arm II: Placebo	Placebo	Patients receive oral placebo 3 pills twice daily

Primary Outcome Measures

Name	Time	Method
Sexual Function	12 weeks	Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	12 weeks	Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.

Trial Locations

Locations (25): CCOP - St. Louis-Cape Girardeau
🇺🇸
Saint Louis, Missouri, United States
MBCCOP - LSU Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States
CCOP - Main Line Health
🇺🇸
Wynnewood, Pennsylvania, United States
Alamance Cancer Center at Alamance Regional Medical Center
🇺🇸
Burlington, North Carolina, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
Cedar Rapids Oncology Associates
🇺🇸
Cedar Rapids, Iowa, United States
CCOP - Heartland Research Consortium
🇺🇸
Saint Louis, Missouri, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸
Winston-Salem, North Carolina, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸
Sioux Falls, South Dakota, United States
CCOP - Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Hugh Chatham Memorial Hospital
🇺🇸
Elkin, North Carolina, United States
Caldwell Memorial Hospital
🇺🇸
Lenoir, North Carolina, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸
Shreveport, Louisiana, United States
CCOP - Beaumont
🇺🇸
Royal Oak, Michigan, United States
CCOP - Central Illinois
🇺🇸
Decatur, Illinois, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸
Ann Arbor, Michigan, United States
CCOP - North Shore University Hospital
🇺🇸
Manhasset, New York, United States
CCOP - Columbus
🇺🇸
Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸
Spartanburg, South Carolina, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center
🇺🇸
East Syracuse, New York, United States
MBCCOP - JHS Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
CCOP - Cancer Research for the Ozarks
🇺🇸
Springfield, Missouri, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸
Augusta, Georgia, United States
Southeastern Medical Oncology Center - Goldsboro
🇺🇸
Goldsboro, North Carolina, United States