L-Arginine Supplements in Treating Women Who Are Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00459134|
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : January 19, 2015
Last Update Posted : September 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sexual Dysfunction Sexuality and Reproductive Issues Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: ArginMax Dietary Supplement: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, 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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
- Sexual Function [ Time Frame: 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.
- Quality of Life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459134
|Principal Investigator:||Kathryn M. Greven, MD||Wake Forest University Health Sciences|