L-Arginine Supplements in Treating Women Who Are Cancer Survivors - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00459134

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Infertility

Drug Information available for: Ginseng Arginine Arginine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Sexual function at 12 weeks

Secondary Outcome Measures:

Quality of life
Toxicity

Estimated Enrollment:	186
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily	Dietary Supplement: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement Given orally
Arm II: Placebo Comparator Patients receive oral placebo twice daily	Other: placebo Given orally

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459134

Show 25 Study Locations

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kathryn M. Greven, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000532277, CCCWFU-05-04-01, CCCWFU-97106
Study First Received:	April 9, 2007
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00459134 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cancer survivor
sexual dysfunction and infertility
sexuality and reproductive issues
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 08, 2010