Clinical trial NCT03173807: Prostate Nutrition and Exercise STudy (ProNEST)
Official title: Prostate Nutrition and Exercise STudy (ProNEST)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metabolic Syndrome
Prostate Cancer
Diet Modification
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot study that will employ a randomized, 2-arm wait-control design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Incidence of metabolic syndrome in Arm A as compared to Arm B at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 24 months
measure: Patient activity
timeFrame: 24 months
measure: Physical function and performance
timeFrame: 24 months
measure: Body composition
timeFrame: 24 months
measure: Adherence to treatment plan
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: UPMC CancerCenter
name: Jennifer McArdle, PA-C
role: PRINCIPAL_INVESTIGATOR
References: