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

ConditionsProstate Carcinoma Recurrent Prostate Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age30-79

SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Antiandrogen Therapy
Drug
Given ADT
Behavioral Intervention
Behavioral
Receive fasting reminders via Oncpatient Companion Mobile Application
Biospecimen Collection
Procedure/Surgery
Undergo blood sample collection
Cardiac Computerized Tomographic Angiography
Procedure/Surgery
Undergo a coronary computerized tomography angiography
Computed Tomography
Procedure/Surgery
Undergo CT
Electronic Health Record Review
Other intervention
Ancillary studies
Internet-Based Intervention
Other intervention
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 intervention
Wear an activity tracker
Nutritional Intervention
Other intervention
Receive AHA HHD guidelines
Nutritional Intervention
Other intervention
Receive AHA Life Essential 8 recommendations with personalized caloric intake
Questionnaire Administration
Other intervention
Ancillary studies
Radiation Therapy
Radiation
Undergo RT
Referral
Other intervention
Receive a referral to an endocrinologist
Semaglutide
Drug
Given SC
Short-Term Fasting
Other intervention
Participate in an overnight fast
Tirzepatide
Drug
Given SC

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Arm 1 (TRE)Experimental treatment 13 interventions

Group B: Arm 2 (semaglutide, tirzepatide)Experimental treatment 14 interventions

Group C: Arm 3 (AHA HDD)Active comparator 11 interventions

Trial outcomes

Primary outcomes

Changes in the 10-year risk of cardiovascular disease

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.

Time frame

At completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT

Changes in the 10-year risk of cardiovascular disease

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.

Time frame