Prostate Nutrition and Exercise STudy (ProNEST)

NCT ID: NCT03173807

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2021-12-31

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.

Conditions

Metabolic Syndrome; Prostate Cancer; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

diet and exercise guidance and modifications

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

diet and exercise guidance and modifications

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jennifer McArdle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer McArdle, PA-C

Role: PRINCIPAL_INVESTIGATOR

UPMC CancerCenter

Other Identifiers

UPCI 16-172

Identifier Type: -

Identifier Source: org_study_id