Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
Start Date
2/27/2025
Completion Date
10/30/2029
Summary
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age \< 40 years (exclusive of breast cancer). II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients. SECONDARY OBJECTIVES: I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients. II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients. EXPLORATORY OBJECTIVE: I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 and 2 years.
Eligibility Criteria
Age Range: No minimum to 39 years
Interventions
Best Practice
Biospecimen Collection
Electronic Health Record Review
Survey Administration
Triptorelin Pamoate
Conditions
Locations
Children's Hospital of Alabama
Birmingham, Alabama 35233
United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
USA Health Strada Patient Care Center
Mobile, Alabama 36604
United States
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202-3591
United States
CARTI Cancer Center
Little Rock, Arkansas 72205
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Mattel Children's Hospital UCLA
Los Angeles, California 90095
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Children's Hospital of Orange County
Orange, California 92868
United States
Sutter Medical Center Sacramento
Sacramento, California 95816
United States
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
United States
Rady Children's Hospital - San Diego
San Diego, California 92123
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado 80218
United States
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United States
Beebe Medical Center
Lewes, Delaware 19958
United States
Beebe South Coastal Health Campus
Millville, Delaware 19967
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware 19803
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
Miami Cancer Institute
Miami, Florida 33176
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
Nemours Children's Hospital
Orlando, Florida 32827
United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida 32504
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
United States
Saint Mary's Medical Center
West Palm Beach, Florida 33407
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia 30329
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
OSF Saint Anthony's Health Center
Alton, Illinois 62002
United States
Rush-Copley Medical Center
Aurora, Illinois 60504
United States
Saint Mary's Hospital
Centralia, Illinois 62801
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
SSM Health Good Samaritan
Mount Vernon, Illinois 62864
United States
Carle BroMenn Medical Center
Normal, Illinois 61761
United States
Carle Cancer Institute Normal
Normal, Illinois 61761
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois 60453
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois 60068
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
Saint John's Hospital
Springfield, Illinois 62702
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Riley Hospital for Children
Indianapolis, Indiana 46202
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United States
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United States
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
United States
Greater Regional Medical Center
Creston, Iowa 50801
United States
Blank Children's Hospital
Des Moines, Iowa 50309
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United States
Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa 50501
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa 50219
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
United States
The Iowa Clinic PC
West Des Moines, Iowa 50266
United States
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
United States
Norton Children's Hospital
Louisville, Kentucky 40202
United States
Children's Hospital New Orleans
New Orleans, Louisiana 70118
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Maine Children's Cancer Program
Scarborough, Maine 04074
United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United States
Christiana Care - Union Hospital
Elkton, Maryland 21921
United States
C S Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan 49009
United States
Beacon Kalamazoo
Kalamazoo, Michigan 49048
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
United States
Munson Medical Center
Traverse City, Michigan 49684
United States
University of Michigan Health - West
Wyoming, Michigan 49519
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
United States
Cox Cancer Center Branson
Branson, Missouri 65616
United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri 63703
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Freeman Health System
Joplin, Missouri 64804
United States
Mercy Hospital Joplin
Joplin, Missouri 64804
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
Lake Regional Hospital
Osage Beach, Missouri 65065
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
United States
Mercy Hospital Springfield
Springfield, Missouri 65804
United States
CoxHealth South Hospital
Springfield, Missouri 65807
United States
Mercy Infusion Center - Chippewa
St Louis, Missouri 63109
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Mercy Hospital South
St Louis, Missouri 63128
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Mercy Hospital Washington
Washington, Missouri 63090
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Presbyterian Hospital
Albuquerque, New Mexico 87106
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Albany Medical Center
Albany, New York 12208
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States
NYP/Weill Cornell Medical Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio 44308
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Dayton Children's Hospital
Dayton, Ohio 45404
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Penn State Children's Hospital
Hershey, Pennsylvania 17033
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Medical City Dallas Hospital
Dallas, Texas 75230
United States
Parkland Memorial Hospital
Dallas, Texas 75235
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
El Paso Children's Hospital
El Paso, Texas 79905
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas 78207
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Carilion Children's
Roanoke, Virginia 24014
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
United States
Madigan Army Medical Center
Tacoma, Washington 98431
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
United States
Sheboygan Physicians Group
Sheboygan, Wisconsin 53081
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
United States
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec H3H 1P3
Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec H3T 1C5
Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, G1V 4G2
Canada