L-Arginine Supplements in Treating Women Who Are Cancer Survivors

Completed · Not applicable · Has a placebo group

Conditions studied: Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00459134

Run by

Wake Forest University Health Sciences

People needed

186

Starts

2007-05-01

Expected to finish

2010-06-01

Last updated by the study team

2021-09-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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