Metabolic SyndromeProNESTNCT03173807
Prostate Nutrition and Exercise STudy (ProNEST)
A study testing diet and exercise guidance and modifications in people with Metabolic Syndrome and Prostate Cancer, run by University of Pittsburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metabolic Syndrome, Prostate Cancer, Diet Modification
- What is being tested?
- diet and exercise guidance and modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
About this study
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.
Read the 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
- Being tested
- diet and exercise guidance and modifications
- Medical subject headings
- Metabolic Syndrome, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and exercise guidance and modificationsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: diet and exercise guidance and modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Quality of life assessment
Quality of life assessed by the FACT-P (version 4) questionnaire
Measured: 24 months
Patient activity
Patient activity using wearable tracking devices and questionnaire
Measured: 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.
Measured: 24 months
Body composition
Body composition with a bioelectrical impedance analyzer. Body fat composition using skin calipers will also be measured
Measured: 24 months
Adherence to treatment plan
Adherence to treatment plan by diet diary, pedometer and activity journal
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start31 Aug 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Unable to find adequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot study that will employ a randomized, 2-arm wait-control design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer McArdle, University of Pittsburgh
- Investigators
- Jennifer McArdle, PA-C, Principal investigator, UPMC CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173807
- Sponsor's protocol ID
- UPCI 16-172
- Acronym
- ProNEST
- Status last verified
- Oct 2017
- First submitted
- 24 May 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Nutrition and Exercise STudy (ProNEST)
- ClinicalTrials.gov ID
- NCT03173807
- Acronym / sponsor ID
- ProNEST / UPCI 16-172
- Conditions
- Metabolic Syndrome, Prostate Cancer, Diet Modification
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to find adequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 31 Aug 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot study that will employ a randomized, 2-arm wait-control design
| Arm | Type | Receives |
|---|---|---|
| dietary and exercise counseling | Active comparator | Behavioral: diet and exercise guidance and modificationsThe 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. |
| standard of care | Active comparator | Behavioral: diet and exercise guidance and modificationsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Current use of taxane based chemotherapy for metastatic disease
- Clinically significant or active cardiovascular disease:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet and exercise guidance and modificationsReview 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 | Behavioural | dietary and exercise counseling, standard of care |
Primary outcome
Incidence of metabolic syndrome in Arm A as compared to Arm B at 12 months
Time frame: 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
5 secondary outcomes
Quality of life assessment
Time frame: 24 months
Patient activity
Time frame: 24 months
Physical function and performance
Time frame: 24 months
Body composition
Time frame: 24 months
Adherence to treatment plan
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer McArdle, PA-C principal investigator
UPMC CancerCenter
Questions about this trial
What is this clinical trial studying?
A study testing diet and exercise guidance and modifications in people with Metabolic Syndrome and Prostate Cancer, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of metabolic syndrome in Arm A as compared to Arm B at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017; AzTrials last refreshed its copy on 29 Oct 2026.