💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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