Clinical trial

Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07202247

Recruiting nowPhase 2Interventional

What this study is about

This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 79 Years

SexMale

Healthy volunteersNot accepted

ConditionProstate Carcinoma, Recurrent Prostate Carcinoma

Full registry criteria

Inclusion Criteria: * Documented informed consent of the participant * English, Spanish or Mandarin-speaking * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Male * Aged: 30-79 * Eastern Cooperative Oncology Group (ECOG) 0-2 * High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as: * Body mass index (BMI) of ≥ 30 kg/m\^2 or * BMI ≥ 27 kg/m\^2 in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia) * Prostate cancer defined as one of the following: * National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months * Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months Exclusion Criteria: * Currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet * Currently under GLP1-RA therapy * Poorly controlled diabetes * Unable to undergo time-restricted diet * Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease * Other active disease deemed not eligible to participant in the study according to treating physician * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Treatments and study arms

Antiandrogen Therapy

Drug

Given ADT

Behavioral Intervention

Behavioral

Receive fasting reminders via Oncpatient Companion Mobile Application

Biospecimen Collection

Procedure

Undergo blood sample collection

Cardiac Computerized Tomographic Angiography

Procedure

Undergo a coronary computerized tomography angiography

Computed Tomography

Procedure

Undergo CT

Electronic Health Record Review

Other

Ancillary studies

Internet-Based Intervention

Other

Complete survey and food diary collection via Oncpatient Companion Mobile Application

Lifestyle Counseling

Behavioral

Receive diet and lifestyle counseling

Medical Device Usage and Evaluation

Other

Wear an activity tracker

Nutritional Intervention

Other

Receive AHA HHD guidelines

Nutritional Intervention

Other

Receive AHA Life Essential 8 recommendations with personalized caloric intake

Questionnaire Administration

Other

Ancillary studies

Radiation Therapy

Radiation

Undergo RT

Referral

Other

Receive a referral to an endocrinologist

Semaglutide

Drug

Given SC

Short-Term Fasting

Other

Participate in an overnight fast

Tirzepatide

Drug

Given SC

Primary outcomes

Changes in the 10-year risk of cardiovascular diseaseAt completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT

The changes in the American Heart Association Predicting Risk of cardiovascular disease (CVD) EVENTs (AHA PREVENT) risk score will be compared between glucagon-like peptide-1 receptor agonist (GLP1-RA) versus (vs.) AHA heart healthy diet (AHA HHD) interventions using a 2-group t-test with a 0.050 one-sided significance level.

Changes in the 10-year risk of cardiovascular diseaseAt completion of 6 months of ADT and at 12 months follow up after completion of ADT

The changes in the AHA PREVENT risk score will be compared between time-restricted eating (TRE) vs. AHA HHD interventions using a 2-group t-test with a 0.050 one-sided significance level.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

City of Hope Medical Center🇺🇸 Duarte, California, United States

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Rose LiContact

Email · Call 508-864-7639

Rose LiPrincipal Investigator