L-Arginine Supplements in Treating Women Who Are Cancer Survivors
A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
3 other identifiers
interventional
186
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Typical duration for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
January 19, 2015
CompletedSeptember 28, 2021
September 1, 2021
3.1 years
April 9, 2007
January 12, 2015
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sexual Function
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.
12 weeks
Secondary Outcomes (1)
Quality of Life
12 weeks
Study Arms (2)
Arm I: ArginMax
EXPERIMENTALArginMax® 3 pills twice daily
Arm II: Placebo
PLACEBO COMPARATORPatients receive oral placebo 3 pills twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Any female cancer survivor who identifies herself as concerned with her sexual quality of life and answering yes to all three of the screening questions.
- Must express interest in sexual activity
- At least 6 months following completion of all cancer therapy. Hormonal therapy and treatment with Herceptin are allowed.
- No evidence of active cancer based on physical exam and/or radiographic images obtained within 3 months of study.
- Absence of any mental, medical or physical disorder know to affect sexual function.
- No participation in another study with an investigational study drug or device during the 30 days prior to start of study drug.
- Lab values must meet the following criteria at study entry: WBC ≥ 2000, Hgb ≥ 10gm/dl, creatinine ≤ 1.5 x ULN, plt ≥ 100,000, T Bili ≤ 1.5
- ECOG performance status must be 0-2.
- Must be able to take oral medication
- Must be 18 years old or older
- Must be minority (non-white) female.
You may not qualify if:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax.
- Currently taking any blood thinner such as aspirin (one 81mg aspirin, or one baby aspirin per day allowed), Persantine, Heparin, Lovenox, or Coumadin (low dose Coumadin for catheter patency is allowed).
- Patients currently taking Ginkgo Biloba are not allowed on this study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or ability for sexual function.
- Pregnant women are excluded from this study because ArginMax may be an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ArginMax, breastfeeding should be discontinued if the mother is treated with ArginMax.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ArginMax. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- Any planned surgery during study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000, United States
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403-1206, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804, United States
CCOP - Heartland Research Consortium
St Louis, Missouri, 63131, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, 13057, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216, United States
Hugh Chatham Memorial Hospital
Elkin, North Carolina, 28621, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Doug Case
- Organization
- Wake Forest NCORP Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn M. Greven, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2007
First Posted
April 11, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
September 28, 2021
Results First Posted
January 19, 2015
Record last verified: 2021-09