Prostate Nutrition and Exercise STudy (ProNEST) (ProNEST)

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.

Study Overview

• Status: Withdrawn
• Conditions: Metabolic Syndrome; Diet Modification; Prostate Cancer
• Intervention / Treatment: Behavioral: diet and exercise guidance and modifications

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dietary and exercise counseling; 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.	Behavioral: diet and exercise guidance and modifications; 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
Active Comparator: standard of care; 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.	Behavioral: diet and exercise guidance and modifications; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of metabolic syndrome in Arm A as compared to Arm B at 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Quality of life assessed by the FACT-P (version 4) questionnaire	24 months
Patient activity	Patient activity using wearable tracking devices and questionnaire	24 months
Physical function and performance	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.	24 months
Body composition	Body composition with a bioelectrical impedance analyzer. Body fat composition using skin calipers will also be measured	24 months
Adherence to treatment plan	Adherence to treatment plan by diet diary, pedometer and activity journal	24 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer McArdle, PA-C, Upmc Cancercenter

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: UPCI 16-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No