L-Arginine Supplements in Treating Women Who Are Cancer Survivors
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.
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: ArginMax
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors|
- Sexual Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I: ArginMax
ArginMax® 3 pills twice daily
Dietary Supplement: ArginMax
Other Name: L-arginine
Placebo Comparator: Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
Dietary Supplement: Placebo
- Determine whether an L-arginine-based nutritional supplement (ArginMax®) improves the quality of life and sexual function in female cancer survivors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459134
Hide Study Locations
|United States, Delaware|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Florida|
|CCOP - Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Georgia|
|MBCCOP - Medical College of Georgia Cancer Center|
|Augusta, Georgia, United States, 30912-4000|
|United States, Illinois|
|MBCCOP - JHS Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Indiana|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Iowa|
|Cedar Rapids Oncology Associates|
|Cedar Rapids, Iowa, United States, 52403-1206|
|United States, Louisiana|
|MBCCOP - LSU Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Michigan|
|CCOP - Michigan Cancer Research Consortium|
|Ann Arbor, Michigan, United States, 48106|
|CCOP - Beaumont|
|Royal Oak, Michigan, United States, 48073-6769|
|United States, Missouri|
|CCOP - Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65804|
|CCOP - Heartland Research Consortium|
|St. Louis, Missouri, United States, 63131|
|CCOP - St. Louis-Cape Girardeau|
|St. Louis, Missouri, United States, 63141|
|United States, New York|
|Hematology Oncology Associates of Central New York, PC - Northeast Center|
|East Syracuse, New York, United States, 13057|
|CCOP - North Shore University Hospital|
|Manhassett, New York, United States, 11030|
|United States, North Carolina|
|Alamance Cancer Center at Alamance Regional Medical Center|
|Burlington, North Carolina, United States, 27216|
|Hugh Chatham Memorial Hospital|
|Elkin, North Carolina, United States, 28621|
|Southeastern Medical Oncology Center - Goldsboro|
|Goldsboro, North Carolina, United States, 27534|
|Caldwell Memorial Hospital|
|Lenoir, North Carolina, United States, 28645|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43215|
|United States, Pennsylvania|
|CCOP - Main Line Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, South Dakota|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|Principal Investigator:||Kathryn M. Greven, MD||Wake Forest NCORP Research Base|