L-Arginine Supplements 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.

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.