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

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ClinicalTrials.gov Identifier: NCT02481648
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Black, MD, Vancouver Prostate Centre

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM1: Exercise Intervention

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.

Other: Exercise
No Intervention: ARM2: Control Group
Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs.



Primary Outcome Measures :
  1. Feasibility: Number of patients screened per month [ Time Frame: From start of recruitment to end of recruitment ]
  2. Feasibility: Number of patients enrolled per month [ Time Frame: From start of recruitment to end of recruitment ]
  3. Feasibility: Proportion of screen eligible patients who enroll [ Time Frame: From start of recruitment to end of recruitment ]
  4. 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 ]
  5. 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 ]
  6. 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 Measures :
  1. Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of activity at baseline, during the study and at the end of the study

  2. Physical Fitness: Anthropometrics (i.e. BMI & waist circumference) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of baseline versus end of study anthropometrics

  3. Physical Fitness: Aerobic fitness using a submaximal graded exercise test [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of baseline versus end of study aerobic fitness

  4. Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of baseline versus end of study functional fitness

  5. Physical Fitness: Muscular strength test upper and lower extremity using the 1RM [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of baseline versus end of study muscular strength

  6. Physical Fitness: Blood pressure and pulse [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of baseline versus end of study blood pressure and pulse

  7. Biological: Collection of urine, blood, biopsy and RP specimens [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Ability to collect these samples for each participant will be assessed

  8. Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study

  9. Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study

  10. Psychosocial: International Prostate Symptom Score (IPSS) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study

  11. Psychosocial: International Index of Erectile Function scale (IIEF) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481648


Locations
Canada, British Columbia
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver Prostate Centre
Investigators
Principal Investigator: Peter Black, MD Department of Urologic Sciences, University of British Columbia

Responsible Party: Peter Black, MD, Urologic Surgeon, Vancouver Prostate Centre
ClinicalTrials.gov Identifier: NCT02481648     History of Changes
Other Study ID Numbers: EMMPC
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Disease Progression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes