Prostate Nutrition and Exercise STudy (ProNEST)

NCT03173807 | Withdrawn DMC

• 1 other identifier: UPCI 16-172
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome; Prostate Cancer; Diet Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life assessment

  24 months

• Patient activity

  24 months

• Physical function and performance

  24 months

• Body composition

  24 months

• Adherence to treatment plan

  24 months

Study Arms (2)

dietary and exercise counseling

ACTIVE COMPARATOR

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

standard of care

ACTIVE COMPARATOR

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

Interventions

diet and exercise guidance and modifications 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

dietary and exercise counseling; standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The disease under study is prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current use of taxane based chemotherapy for metastatic disease
• Clinically significant or active cardiovascular disease:
• No previous MI within the past 12 months
• No uncontrolled angina within 12 months
• History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
• Uncontrolled hypertension (systolic BP \> 170 mmHg or diastolic BP \> 100 mmHg at screening)
• CHF with NYHA class 3 or 4
• Structurally unstable bone lesions suggesting impending fracture
• Estimated life expectancy of \< 6 months
• Patients who meet criteria for metabolic syndrome that are uncontrolled based on the Internal Diabetes Federation.

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Metabolic Syndrome; Prostatic Neoplasms

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jennifer McArdle, PA-C

  UPMC CancerCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pilot study that will employ a randomized, 2-arm wait-control design

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 2, 2017
• Study Start: August 31, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share