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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 39 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether tirzepatide may help prevent heart damage linked to excess weight in young adult cancer survivors. It is for adults ages 18–39 who are overweight or obese, finished chemotherapy for soft tissue or bone sarcoma, and have good heart pumping strength.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–39 years old.
- Have soft tissue or bone sarcoma confirmed by a tissue test, treated with at least 300 mg/m² of doxorubicin chemotherapy.
- Have finished chemotherapy about 3 months ago and be in remission, meaning the cancer is not active. Have no cancer drug treatment, radiation, or cancer surgery planned for the next 12 months.
- Have a BMI of 30 or higher, or a BMI of 25–29.9 plus at least one heart or blood vessel risk factor. BMI is a measure of weight compared with height.
- Have a heart pumping strength, called LVEF, of at least 50% and no heart failure symptoms.
- Be able to care for yourself and be up and moving for at least half of your waking hours.
- Women who could become pregnant must use birth control during tirzepatide treatment. Men must use birth control during treatment and for 4 months after. Pregnancy testing follows the study center's policy.
- Be able to give informed consent and agree to all study visits, tests, and follow-up.
Who can't join
- Have diabetes that needs medicine.
- Have used or currently use a GLP-1 medicine, a type of medicine used for diabetes or weight loss, or have a medical reason you cannot take GLP-1/GIP medicines.
- Have active cancer or are receiving cancer drug treatment.
- Still have side effects from past cancer treatment that are more than mild, except hair loss.
- Have a history of pancreatitis (swelling of the pancreas), medullary thyroid cancer, or MEN2 (an inherited condition that can cause tumors).
- Are taking part in another study that tests a treatment or procedure.
- Are pregnant or breastfeeding.
- Have a mental health condition or life situation that would make it hard to follow study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
TX
- UT MD Anderson · Houston, TX 77030More trials in Houston