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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07874828
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Sarcoma,Soft Tissue

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 15, 2026
Start date
Dec 31, 2026
Status verified
Oct 2026
Primary completion
Dec 31, 2034
Completion
Dec 31, 2036

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Phase II: Treatment with Tirzepatide
    Tirz will be administered as a once-weekly subcutaneous injection using single-dose vials, and a needle and syringe to draw up and administer the prescribed dose. Participants will self-administer the medication after training by the clinical team or pharmacy, including proper needle and syringe technique.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030-

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By research site
UT MD Anderson· Houston, TX

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