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| 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 |
| 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
|
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.
Eligibility| 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:
Contacts and Locations
Hide Study Locations| 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 | |
| United States, Georgia | |
| MBCCOP - Medical College of Georgia Cancer Center | Recruiting |
| Augusta, Georgia, United States, 30912-4000 | |
| Contact: Angela Goebel, BS 706-721-8944 | |
| 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, New York | |
| CCOP - North Shore University Hospital | Recruiting |
| Manhassett, New York, United States, 11030 | |
| Contact: Kerry O 516-743-8913 | |
| Hematology Oncology Associates of Central New York, PC - Northeast Center | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Colleen Sweeney 315-472-7504 ext. 2129 | |
| United States, North Carolina | |
| 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 | |
| Caldwell Memorial Hospital | Recruiting |
| Lenoir, North Carolina, United States, 28645 | |
| Contact: Theodore E. Yaeger, MD, FACRO 828-759-4960 | |
| Alamance Cancer Center at Alamance Regional Medical Center | Recruiting |
| Burlington, North Carolina, United States, 27216 | |
| Contact: Janak K. Choksi, MD 336-538-7737 | |
| 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, Pennsylvania | |
| CCOP - Main Line Health | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Maria Hendricks, MSN, RN 610-645-2649 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| Contact: Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org | |
| Principal Investigator: | Kathryn M. Greven, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000532277, CCCWFU-05-04-01, CCCWFU-97106 |
| Study First Received: | April 9, 2007 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00459134 History of Changes |
| Health Authority: | Unspecified |
|
cancer survivor sexual dysfunction and infertility sexuality and reproductive issues unspecified adult solid tumor, protocol specific |
|
Genital Diseases, Female Infertility Genital Diseases, Male |