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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00459134 |
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 |
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Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement Drug: 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 |
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 |
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Arm I: Experimental
Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily
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Drug: L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo twice daily
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Minority (non-white) female cancer survivor
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No concurrent blood thinner, including any of the following:
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 |
Principal Investigator: | Kathryn M. Greven, MD | Wake Forest University |
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 |
sexual dysfunction and infertility sexuality and reproductive issues unspecified adult solid tumor, protocol specific |
Infertility Quality of Life |