Spots Global Cancer Trial Database for L-Arginine Supplements in Treating Women Who Are Cancer Survivors
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Trial Identification
Brief Title: L-Arginine Supplements in Treating Women Who Are Cancer Survivors
Official Title: A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Study ID: NCT00459134
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
CCOP - Christiana Care Health Services, Newark, Delaware, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
MBCCOP - JHS Hospital of Cook County, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
CCOP - Heartland Research Consortium, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center, East Syracuse, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina, United States
Hugh Chatham Memorial Hospital, Elkin, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina, United States
Caldwell Memorial Hospital, Lenoir, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Contact Details
Name: Kathryn M. Greven, MD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR
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