Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
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 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.
Arms & interventions
- OtherBest Practice
Receive standard chemotherapy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherSurvey Administration
Ancillary studies
- DrugTriptorelin Pamoate
Given IM
Outcome measures
Primary
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time. Will help determine if a larger efficacy study can be successfully completed as a cross network trial in a reasonable funding period.
Time frame: Up to 2 years post-chemotherapy
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Time frame: Up to 2 years post-chemotherapy
Anti-mullerian hormone (AMH) levels
AMH values will be examined to confirm that the combined variability of AMH in both arms is consistent with our a priori assumptions.
Time frame: At 2 years post-chemotherapy
Secondary
Longitudinal AMH along with other ovarian hormone levels
Time frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Hot flashes
Time frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Headaches
Time frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Vaginal/vulvar symptoms
Time frame: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Sexual function
Time frame: Up to 2 years post-chemotherapy
Sexual Health
Time frame: Up to 2 years post-chemotherapy
Menstrual patterns
Time frame: Up to 2 years post-chemotherapy
Global health-related quality of life: Anxiety
Time frame: Up to 2 years post-chemotherapy
Global health-related quality of life: Fatigue
Time frame: Up to 2 years post-chemotherapy
Global health-related quality of life: Depression
Time frame: Up to 2 years post-chemotherapy
Global health-related quality of life: Sleep disturbance
Time frame: Up to 2 years post-chemotherapy
Global health-related quality of life: Participation in social activities
Time frame: Up to 2 years post-chemotherapy
Eligibility criteria
Study locations (190)
Children's Hospital of Alabama
Birmingham, Alabama, 35233
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
CARTI Cancer Center
Little Rock, Arkansas, 72205
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Loma Linda University Medical Center
Loma Linda, California, 92354
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Kaiser Permanente-Oakland
Oakland, California, 94611
Children's Hospital of Orange County
Orange, California, 92868
Sutter Medical Center Sacramento
Sacramento, California, 95816
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Rady Children's Hospital - San Diego
San Diego, California, 92123
Children's Hospital Colorado
Aurora, Colorado, 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Beebe Medical Center
Lewes, Delaware, 19958
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Nicklaus Children's Hospital
Miami, Florida, 33155
Miami Cancer Institute
Miami, Florida, 33176
AdventHealth Orlando
Orlando, Florida, 32803
Nemours Children's Hospital
Orlando, Florida, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Tampa General Hospital
Tampa, Florida, 33606
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Rush-Copley Medical Center
Aurora, Illinois, 60504
Saint Mary's Hospital
Centralia, Illinois, 62801
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
University of Illinois
Chicago, Illinois, 60612
Carle at The Riverfront
Danville, Illinois, 61832
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Carle BroMenn Medical Center
Normal, Illinois, 61761
Carle Cancer Institute Normal
Normal, Illinois, 61761
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Memorial Hospital East
Shiloh, Illinois, 62269
Saint John's Hospital
Springfield, Illinois, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Carle Cancer Center
Urbana, Illinois, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Greater Regional Medical Center
Creston, Iowa, 50801
Blank Children's Hospital
Des Moines, Iowa, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa, 50219
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Norton Children's Hospital
Louisville, Kentucky, 40202
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Maine Children's Cancer Program
Scarborough, Maine, 04074
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Christiana Care - Union Hospital
Elkton, Maryland, 21921
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Bronson Battle Creek
Battle Creek, Michigan, 49017
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Munson Medical Center
Traverse City, Michigan, 49684
University of Michigan Health - West
Wyoming, Michigan, 49519
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Cox Cancer Center Branson
Branson, Missouri, 65616
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Lake Regional Hospital
Osage Beach, Missouri, 65065
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital South
St Louis, Missouri, 63128
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Mercy Hospital Washington
Washington, Missouri, 63090
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Presbyterian Hospital
Albuquerque, New Mexico, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Albany Medical Center
Albany, New York, 12208
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
NYP/Weill Cornell Medical Center
New York, New York, 10065
University of Rochester
Rochester, New York, 14642
Stony Brook University Medical Center
Stony Brook, New York, 11794
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dayton Children's Hospital
Dayton, Ohio, 45404
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Oregon Health and Science University
Portland, Oregon, 97239
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Rhode Island Hospital
Providence, Rhode Island, 02903
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Medical City Dallas Hospital
Dallas, Texas, 75230
Parkland Memorial Hospital
Dallas, Texas, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
El Paso Children's Hospital
El Paso, Texas, 79905
Cook Children's Medical Center
Fort Worth, Texas, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Children's Hospital of San Antonio
San Antonio, Texas, 78207
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Carilion Children's
Roanoke, Virginia, 24014
Seattle Children's Hospital
Seattle, Washington, 98105
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Madigan Army Medical Center
Tacoma, Washington, 98431
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495