Prostate Nutrition and Exercise STudy (ProNEST)

Not Applicable

Withdrawn

• Conditions: Metabolic Syndrome; Diet Modification; Prostate Cancer
• Interventions: Behavioral: diet and exercise guidance and modifications

• Registration Number: NCT03173807
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of this study is to test the feasibility of nutrition and exercise counseling program for reducing the incidence of metabolic syndrome in prostate cancer patients on Androgen Deprivation Therapy.

Detailed Description

This is a pilot study to evaluate the role of dietary modifications and exercise in patients started on ADT for preventing and or delaying metabolic syndrome in this aging population. The study will employ a randomized, 2-arm wait-control design. Subjects will be randomized in a 1:1 ratio into two arms: dietary modifications and exercise counseling (Arm A) or standard of care (Arm B). The duration of intervention in Arm A will be 24 months. At 12 months, participants in Arm B will be offered the same intervention that Arm A received during months 1-12. Medical records will be accessed up to 5 years for standard of care visits. The goal of this project is to generate preliminary data on the feasibility of applying such an intervention on a much bigger population with approximately 100 subjects on each arm. For this pilot, we aim to randomize 20 patients to each arm. The principal investigator or co-investigators who are evaluating the patient will perform the randomization since this is an open-label, non-therapeutic study. The ADT received by patients on both arms is considered standard of care therapy for their prostate cancer.

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-02
• Study Start: 2017-08-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06
• Primary Completion: 2019-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient has provided written, informed consent
2. 18 years of age or greater
3. Histologically or biochemically confirmed hormone-naïve prostate adenocarcinoma
4. Recently started or re-started ADT within 4 months of starting the study
5. Eastern Oncology Co-operative Group (ECOG) performance 0-1
6. Patient who is on an antihypertensive medications with a blood pressure less than 130 systolic and 85 mm Hg diastolic
7. Patient who is on an antihyperlipidemic agents with TG ≤ 150 mg/dl, serum HDL ≥40 mg/dL

Exclusion Criteria

1. Current use of taxane based chemotherapy for metastatic disease

2. Clinically significant or active cardiovascular disease:

   1. No previous MI within the past 12 months
   2. No uncontrolled angina within 12 months
   3. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
   4. Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 100 mmHg at screening)
   5. CHF with NYHA class 3 or 4

3. Structurally unstable bone lesions suggesting impending fracture

4. Estimated life expectancy of < 6 months

5. Patients who meet criteria for metabolic syndrome that are uncontrolled based on the Internal Diabetes Federation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care	diet and exercise guidance and modifications	The duration of study in Arm B will be 24 months, with study assessments and interventions (review of diet, food diary, and guidance from the dietician; review of activity journal, assessment of body composition, tests for gait, balance and muscle strength, and new assignment from the exercise trainer) done at baseline, 12 months, 15 months, 18 months and 24 months. At 12 months, participants in Arm B will be offered the same intervention that Arm A received during months 1-12.
dietary and exercise counseling	diet and exercise guidance and modifications	The duration of study in Arm A will be 24 months, with study assessments and interventions (review of diet, food diary, and guidance from the dietician; review of activity journal, assessment of body composition, tests for gait, balance and muscle strength, and new assignment from the exercise trainer) done at baseline, 3 months, 6 months, 12 months and 24 months.

Primary Outcome Measures

Name	Time	Method
Incidence of metabolic syndrome in Arm A as compared to Arm B at 12 months	12 months	Metabolic syndrome will be defined by the following measurements: weight circumference, BMI, blood tests (Fasting glucose, Hemoglobin A1c, Lipid Panel, LDH and blood pressure), blood pressure. The information will be collected from medical records of standard of care visits

Secondary Outcome Measures

Name	Time	Method
Patient activity	24 months	Patient activity using wearable tracking devices and questionnaire
Quality of life assessment	24 months	Quality of life assessed by the FACT-P (version 4) questionnaire
Physical function and performance	24 months	Performance testing will be done using the following measure: short physical performance battery of balance, gait speed measuring physical function, and chair stand measuring lower body muscular endurance; an arm curl test measuring upper body muscular endurance, back scratch test measuring upper body flexibility, and chair sit-and-reach test measuring lower body flexibility. Anthropometric measurements will be completed measuring body mass index, abdominal girth with measuring tape.
Body composition	24 months	Body composition with a bioelectrical impedance analyzer. Body fat composition using skin calipers will also be measured
Adherence to treatment plan	24 months	Adherence to treatment plan by diet diary, pedometer and activity journal