L-Arginine Supplements in Treating Women Who Are Cancer Survivors
NCT ID: NCT00459134
Last Updated: 2021-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2007-05-01
2010-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Arm I: ArginMax
ArginMax® 3 pills twice daily
ArginMax
Given orally
Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
Placebo
Given orally
Interventions
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ArginMax
Given orally
Placebo
Given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Kathryn M. Greven, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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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 - Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Heartland Research Consortium
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, 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
Countries
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Other Identifiers
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REBACCCWFU 97106
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00001487
Identifier Type: -
Identifier Source: org_study_id
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