L-Arginine Supplements in Treating Women Who Are Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

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

Intervention / Treatment
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* Dietary Supplement: ArginMax
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: ArginMax<br>ArginMax® 3 pills twice daily | Dietary Supplement: ArginMax<br>* Given orally<br>* Other names: L-arginine;|
| Placebo Comparator: Arm II: Placebo<br>Patients receive oral placebo 3 pills twice daily | Dietary Supplement: Placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual dysfunction, sexuality and reproductive issues, unspecified adult solid tumor, protocol specific