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Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer (EMMPC)

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

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

Inclusion criteria:

Completed Pre-Screening Consent Form
Men with CaP, who are deemed suitable by a urologist for RP
Engaging in <90 minutes/week of moderate-to-vigorous exercise
BMI <40
Age >19
Able to speak and read English (to be able to complete questionnaires)
Willing to comply with all study procedures (including committing to twice-weekly visits to the study exercise facility and exercise at home) and be available for the duration of the study
Provide signed and dated informed consent form

Exclusion Criteria:

• Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.

Sites / Locations

Vancouver Prostate Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ARM1: Exercise Intervention

ARM2: Control Group

Arm Description

The exercise program is a 4-12 weeks progressive combined resistance and aerobic exercise for participants from time of diagnosis to RP. Participants will undergo twice weekly group-training (four-six participants/group) combined aerobic-resistance sessions (1hr per session), supervised by trained exercise therapists. In addition, participants will undergo home-based aerobic exercise independently three times a week with the goal to meet the current physical activity guidelines for cancer survivors (150min/week of moderate intensity aerobic activity and two resistance training sessions per week). Participants will also be supplied with the Canadian Physical Activity and Sedentary Behavior Guidelines Handbook and accompanying Log Sheets.

Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs.

Outcomes

Primary Outcome Measures

Feasibility: Number of patients screened per month

Feasibility: Number of patients enrolled per month

Feasibility: Proportion of screen eligible patients who enroll

Feasibility: Treatment-specific retention rates

Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm

Feasibility: Proportion of planned assessments that are completed respectively

Secondary Outcome Measures

Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs

Comparison of activity at baseline, during the study and at the end of the study

Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)

Comparison of baseline versus end of study anthropometrics

Physical Fitness: Aerobic fitness using a submaximal graded exercise test

Comparison of baseline versus end of study aerobic fitness

Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl

Comparison of baseline versus end of study functional fitness

Physical Fitness: Muscular strength test upper and lower extremity using the 1RM

Comparison of baseline versus end of study muscular strength

Physical Fitness: Blood pressure and pulse

Comparison of baseline versus end of study blood pressure and pulse

Biological: Collection of urine, blood, biopsy and RP specimens

Ability to collect these samples for each participant will be assessed

Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P)

Comparison of questionnaire scores at baseline versus end of study

Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D)

Comparison of questionnaire scores at baseline versus end of study

Psychosocial: International Prostate Symptom Score (IPSS)

Comparison of questionnaire scores at baseline versus end of study

Psychosocial: International Index of Erectile Function scale (IIEF)

Comparison of questionnaire scores at baseline versus end of study

Full Information

NCT ID

NCT02481648

First Posted

January 27, 2015

Last Updated

April 17, 2023

Sponsor

Vancouver Prostate Centre

1. Study Identification

Unique Protocol Identification Number

NCT02481648

Brief Title

Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer

Acronym

EMMPC

Official Title

A Pilot Study to Evaluate Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2015 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vancouver Prostate Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM1: Exercise Intervention

Arm Type

Experimental

Arm Description

Arm Title

ARM2: Control Group

Arm Type

No Intervention

Arm Description

Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs.

Intervention Type

Other

Intervention Name(s)

Exercise

Primary Outcome Measure Information:

Title

Feasibility: Number of patients screened per month

Time Frame

From start of recruitment to end of recruitment

Title

Feasibility: Number of patients enrolled per month

Time Frame

From start of recruitment to end of recruitment

Title

Feasibility: Proportion of screen eligible patients who enroll

Time Frame

From start of recruitment to end of recruitment

Title

Feasibility: Treatment-specific retention rates

Time Frame

From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks

Title

Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm

Time Frame

From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks

Title

Feasibility: Proportion of planned assessments that are completed respectively

Time Frame

From date of randomization to end of study for each participant, an average of 7 months

Secondary Outcome Measure Information:

Title

Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs

Description

Comparison of activity at baseline, during the study and at the end of the study

Time Frame