PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study
M.D. Anderson Cancer Center
Summary
This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic. The study will enroll young adults (18-39 years) with soft tissue or bone sarcoma who are overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²), have completed Dox-based chemotherapy (≥300 mg/m²) approximately three months prior to enrollment, and have preserved LVEF (≥50%) preenrollment.
Description
Primary Objectives: To evaluate the feasibility of administering Tirz in overweight or obese AYA sarcoma patients during the first year after anthracycline therapy. Feasibility will be assessed as a composite of recruitment, retention, and treatment adherence, and will be considered if all the following criteria are achieved: * Enrollment: ≥40% of eligible patients offered participation to enroll. * Visit completion: ≥70% of enrolled participants complete ≥70% of scheduled study visits through end of year one (≥5 out of 6 visits). * Treatment adherence: ≥70% of participants receive ≥70% of…
Eligibility
- Age range
- 18–39 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-39 years at enrollment * Histologically confirmed soft tissue or bone sarcoma with treatment that included Dox ≥ 300 mg/m². * Completed chemotherapy 3 months prior to enrollment; patient must be in remission at the time of enrollment with no planned systemic therapy, radiation therapy, or surgical oncologic intervention anticipated within the next 12 months. * Overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²) at the time of enrollment. * LVEF ≥ 50% at the time of enrollment with no symptoms of heart failure (NYHA class I-II…
Interventions
- DrugTirzepatide
Given by injection
Location
- UT MD AndersonHouston, Texas