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
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cancer
- Who it enrolls
- age 18 Years to 39 Years; excludes diabetes; BMI ≥30 required; conditions: Sarcoma,Soft Tissue
- Interventions
- Tirzepatide
- Conditions
- Sarcoma,Soft Tissue
- Phase and size
- Phase 2 · 30 participants
- Dates
- Start 2026-12-31
Primary completion 2034-12-31 - Sponsor
- M.D. Anderson Cancer Center (Other)
- Last checked
- Oct 18, 2026
01Endpoints
What the trial will measure
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
02Eligibility
Who can take part
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). * ECOG performance status ≤2 (equivalent to Karnofsky ≥60%) at the time of enrollment. * Reproductive considerations: * Women of childbearing potential must agree to use adequate contraception (hormonal, barrier, IUD, or abstinence) beginning at enrollment and continuing for the duration of Tirz therapy. * Men must agree to use adequate contraception during study treatment and for 4 months after completion of Tirz. * Pregnancy testing will follow MD Anderson Policy CLN1114. * Ability to provide informed consent and willingness to comply with all study procedures, assessments, and follow-up requirements. Exclusion Criteria: * Preexisting diabetes mellitus requiring pharmacologic therapy. * Prior or current use of GLP-1 receptor agonists. * Ongoing active malignancy or ongoing systemic therapy for cancer treatment. * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. * History of pancreatitis, medullary thyroid carcinoma, or MEN2. * Current participation in another interventional trial. * Pregnancy or breastfeeding. * Contraindication to GLP-1/GIP receptor agonists. * Psychiatric illness/social situations that would limit compliance with study requirements.
03Change log
Registry changes
No changes recorded since the trial was added.