NCT07874828 · M.D. Anderson Cancer Center
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
What this study is about
This is a forward-looking, single-treatment group$1, where both patients and doctors know the treatment given 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.
View original scientific description
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.
Interventions
DRUG
Tirzepatide
Given by injection
Primary outcome measures
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2026 · Source of record for eligibility and locations