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Prostate Nutrition and Exercise STudy (ProNEST) (ProNEST)

Primary Purpose

Metabolic Syndrome, Prostate Cancer, Diet Modification

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diet and exercise guidance and modifications
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    dietary and exercise counseling

    standard of care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 24, 2017
    Last Updated
    October 4, 2017
    Sponsor
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03173807
    Brief Title
    Prostate Nutrition and Exercise STudy (ProNEST)
    Acronym
    ProNEST
    Official Title
    Prostate Nutrition and Exercise STudy (ProNEST)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to find adequate funding
    Study Start Date
    August 31, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Prostate Cancer, Diet Modification

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a pilot study that will employ a randomized, 2-arm wait-control design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dietary and exercise counseling
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    standard of care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet and exercise guidance and modifications
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Incidence of metabolic syndrome in Arm A as compared to Arm B at 12 months
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Quality of life assessment
    Description
    Quality of life assessed by the FACT-P (version 4) questionnaire
    Time Frame
    24 months
    Title
    Patient activity
    Description
    Patient activity using wearable tracking devices and questionnaire
    Time Frame
    24 months
    Title
    Physical function and performance
    Description
    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.
    Time Frame
    24 months
    Title
    Body composition
    Description
    Body composition with a bioelectrical impedance analyzer. Body fat composition using skin calipers will also be measured
    Time Frame
    24 months
    Title
    Adherence to treatment plan
    Description
    Adherence to treatment plan by diet diary, pedometer and activity journal
    Time Frame
    24 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    The disease under study is prostate cancer
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has provided written, informed consent 18 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 Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer McArdle, PA-C
    Organizational Affiliation
    UPMC CancerCenter
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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