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L-Arginine Supplements in Treating Women Who Are Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459134
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : January 19, 2015
Last Update Posted : September 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 to see how well it works compared with a placebo in treating women who are cancer survivors.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Sexuality and Reproductive Issues Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: ArginMax Dietary Supplement: Placebo Not Applicable

Detailed Description:



  • Determine whether an L-arginine-based nutritional supplement (ArginMax®) improves the quality of life and sexual function in female cancer survivors.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Study Start Date : May 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Arginine

Arm Intervention/treatment
Experimental: Arm I: ArginMax
ArginMax® 3 pills twice daily
Dietary Supplement: ArginMax
Given orally
Other Name: L-arginine

Placebo Comparator: Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
Dietary Supplement: Placebo
Given orally

Primary Outcome Measures :
  1. Sexual Function [ Time Frame: 12 weeks ]
    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.

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459134

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Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Principal Investigator: Kathryn M. Greven, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00459134    
Other Study ID Numbers: IRB00001487
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU 97106 ( Other Identifier: NCI )
First Posted: April 11, 2007    Key Record Dates
Results First Posted: January 19, 2015
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
sexual dysfunction
sexuality and reproductive issues
unspecified adult solid tumor, protocol specific