Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

FEMALE

Age

N/A - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Receive standard chemotherapy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Electronic Health Record Review — OTHER
  Ancillary studies
• Survey Administration — OTHER
  Ancillary studies
• Triptorelin Pamoate — DRUG
  Given IM

Study Details

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.

Key Dates

Start date

Feb 27, 2025

Status verified

May 2025

Primary completion

Oct 30, 2029

Completion

Oct 30, 2029

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Arm A (triptorelin)
  Patients receive triptorelin 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.
• Active Comparator: Arm B (usual care)
  Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

Primary Outcome Measure

Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years [ Time Frame: Up to 2 years post-chemotherapy ]

Locations (190)

Find similar trials in Birmingham, AL

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