L-Arginine Supplements in Treating Women Who Are Cancer Survivors



Status:Completed
Conditions:Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:May 2007
End Date:June 2010

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

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.

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.
We found this trial at
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Chicago, Illinois 60612
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300 Community Drive
Manhasset, New York 11030
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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1120 15th Street, BAA-5407
Augusta, Georgia 30912
(706) 721-2505
MBCCOP - Medical College of Georgia Cancer Center The Georgia Regents University (GRU) is located...
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Burlington, NC
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525 10th St SE
Cedar Rapids, Iowa 52403
(319) 363-8303
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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Columbus, OH
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Decatur, Illinois 62526
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East Syracuse, NY
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Elkin, North Carolina 28621
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Goldsboro, North Carolina 27534
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Lenoir, North Carolina 28645
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63131
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Saint Louis, Missouri 63141
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Sioux Falls, South Dakota 57104
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South Bend, Indiana 46601
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Spartanburg, South Carolina 29303
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Wynnewood, Pennsylvania 19096
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