Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513962
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 physicians 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
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 ie 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 physicians 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None