A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
- 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®)
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Determine whether ArginMax improves the quality of life and sexual function.
Determine whether ArginMax improves the quality of life and sexual function for women cancer survivors by using the FACT-G and FSFI instruments.
Kathryn M. Greven, MD
Wake Forest Cancer Center CCOP Research Base
United States: Food and Drug Administration
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|Cedar Rapids Oncology Associates||Cedar Rapids, Iowa 52403|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|MBCCOP - Medical College of Georgia Cancer Center||Augusta, Georgia 30912-3730|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|CCOP - Main Line Health||Wynnewood, Pennsylvania 19096|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|MBCCOP - JHS Hospital of Cook County||Chicago, Illinois 60612|
|Hugh Chatham Memorial Hospital||Elkin, North Carolina 28621|
|Caldwell Memorial Hospital||Lenoir, North Carolina 28645|
|Southeastern Medical Oncology Center - Goldsboro||Goldsboro, North Carolina 27534|
|Hematology Oncology Associates of Central New York, PC - Northeast Center||East Syracuse, New York 13057-4510|
|CCOP - Heartland Research Consortium||St. Louis, Missouri 63131|