Status:
COMPLETED
L-Arginine Supplements in Treating Women Who Are Cancer Survivors
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sexual Dysfunction
Sexuality and Reproductive Issues
Eligibility:
FEMALE
18+ years
Phase:
NA
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 t...
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 qual...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00459134
Start Date
May 1 2007
End Date
June 1 2010
Last Update
September 28 2021
Active Locations (25)
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1
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
2
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
3
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
4
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612