• Quality of life
• Toxicity

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.

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.

• Cancer Survivor
• Sexual Dysfunction and Infertility
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific

• Dietary Supplement: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement
• Other: placebo

• Experimental: Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily
• Placebo Comparator: Patients receive oral placebo twice daily

DISEASE CHARACTERISTICS:

• Minority (non-white) female cancer survivor

  • No active cancer based on physical exam and radiographic images obtained within the past 3 months
• Concerned with sexual quality of life
• Must express interest in sexual activity

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Hemoglobin ≥ 10 g/dL
• Creatinine ≤ 1.5 mg/dL
• WBC ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• No mental, medical, or physical disorder known to affect sexual function
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to ArginMax®

• No uncontrolled intercurrent illness including, but not limited to, the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would preclude study compliance and/or ability for sexual function

PRIOR CONCURRENT THERAPY:

• At least 1 month since prior participation in another study with an investigational drug or device
• At least 6 months since prior cancer therapy

• No concurrent blood thinner, including any of the following:

  • acetylsalicylic acid (aspirin) (one 81 mg aspirin, or one baby aspirin per day allowed)
  • warfarin (low-dose warfarin for catheter patency allowed)
  • dipyridamole
  • heparin
  • enoxaparin
• No concurrent surgery
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent EGb761 (ginkgo biloba)
• Concurrent hormonal therapy and trastuzumab (Herceptin®) allowed