NCT07874828RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Dec 2034
- Lead sponsor
- M.D. Anderson Cancer Center
- NCT number
- NCT07874828
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From Oct 2026 to the primary completion date, Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current use of GLP-1 receptor agonists.
- 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.
Other illness
- Preexisting diabetes mellitus requiring pharmacologic therapy.
- Ongoing active malignancy or ongoing systemic therapy for cancer treatment.
- History of pancreatitis, medullary thyroid carcinoma, or MEN2.
- Psychiatric illness/social situations that would limit compliance with study requirements.
Other
- Current participation in another interventional trial.
- Pregnancy or breastfeeding.
- Contraindication to GLP-1/GIP receptor agonists.
Who the study is looking for
- 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.
Age in the registry: 18 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.