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L-Arginine Supplements in Treating Women Who Are Cancer Survivors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Wake Forest University
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-Related Problem/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Drug: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement
Drug: placebo

MedlinePlus related topics: Cancer Dietary Supplements
Drug Information available for: Arginine Ginseng Arginine hydrochloride
U.S. FDA Resources
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

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
Drug: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement
Given orally
Arm II: Placebo Comparator
Patients receive oral placebo twice daily
Drug: 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

Locations
United States, California
CCOP - Santa Rosa Memorial Hospital Recruiting
Santa Rosa, California, United States, 95403
Contact: Ian C. Anderson, MD     707-521-3830        
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Stephen S. Grubbs, MD     302-733-6227        
United States, Florida
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Rogerio C. Lilenbaum, MD     305-674-2625        
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
United States, Illinois
CCOP - Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade, MD     217-876-6617     jlwade3@sbcglobal.net    
MBCCOP - JHS Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Howard A. Zaren, MD, FACS     312-864-5204     hazaren@msn.com    
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Mary Jean Wasielewski     574-647-7370     mwasielewski@memorialsb.org    
United States, Iowa
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403-1206
Contact: Martin Wiesenfeld, MD     319-363-8303     mwiesenfeld@iowacancercare.com    
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Recruiting
Shreveport, Louisiana, United States, 71130-3932
Contact: Glenn M. Mills, MD     318-813-1442     gmills@lsuhsc.edu    
MBCCOP - LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith, MD     504-896-9740        
United States, Michigan
CCOP - Beaumont Recruiting
Royal Oak, Michigan, United States, 48073-6769
Contact: David A. Decker, MD, FACP     248-551-6900     ddecker@beaumont.edu    
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD     734-712-1000        
United States, Missouri
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65804
Contact: John W. Goodwin, MD     417-889-8099     jgoodwin@sprg.mercy.net    
CCOP - Heartland Research Consortium Recruiting
St. Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD     314-996-5569     jmr2166@bjc.org    
CCOP - St. Louis-Cape Girardeau Recruiting
St. Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD     314-251-6573        
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center Recruiting
Burlington, North Carolina, United States, 27216
Contact: Janak K. Choksi, MD     336-538-7737        
Caldwell Memorial Hospital Recruiting
Lenoir, North Carolina, United States, 28645
Contact: Theodore E. Yaeger, MD, FACRO     828-759-4960        
Hugh Chatham Memorial Hospital Recruiting
Elkin, North Carolina, United States, 28621
Contact: Clinical Trials Office - Hugh Chatham Memorial Hospital     336-527-7577     info@hughchatham.org    
Southeastern Medical Oncology Center - Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000     jatkins@cancersmoc.com    
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD     614-566-5274     kueblep@ohiohealth.com    
United States, South Carolina
CCOP - Upstate Carolina Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina     800-486-5941        
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Kathryn M. Greven, MD Wake Forest University
  More Information

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

Study ID Numbers: CDR0000532277, CCCWFU-05-04-01, CCCWFU-97106
Study First Received: April 9, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00459134  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction and infertility
sexuality and reproductive issues
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Infertility
Quality of Life

ClinicalTrials.gov processed this record on January 14, 2009