Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266262
Recruitment Status : Suspended (All research activities were suspended as a result of COVID-19.)
First Posted : February 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Daniel Santa Mina, PhD, University of Toronto

Brief Summary:
This is a randomized study aiming to assess the feasibility of a phase II randomized controlled trial of different high-intensity training interventions and usual care (UC) in men with prostate cancer (PCa) undergoing active surveillance (AS).

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: High-intensity interval training (HIIT) Behavioral: High-Intensity resistance training (HIRT) Not Applicable

Detailed Description:

Primary objectives:

The primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (HIIT), high-intensity resistance training (HIRT), and usual care (UC) in men with PCa on AS.

The secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of HIIT, HIRT, or UC.

Methods:

Participants will be randomized in a 1:1:1 ratio to HIIT, HIRT or UC group.

Participants in the HIIT and HIRT group will undergo training 3 times per week (two supervised and one home-based/unsupervised training session) for 8 weeks.

The UC group will be directed towards publicly available literature on physical activity (e.g., Cancer Care Ontario's physical activity guidelines for cancer survivors) and will receive an individualized exercise program upon completion of their final fitness assessment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
Actual Study Start Date : July 9, 2018
Actual Primary Completion Date : March 18, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: High-Intensity interval training (HIIT) Behavioral: High-intensity interval training (HIIT)

Supervised HIIT sessions (2x/week) will comprise cycling 10 x 60 secs at 85-95% maximum heart rate (HRmax) interspersed by 60 secs of low-intensity recovery.

Unsupervised HIIT sessions (1x/week) will involve 10 x 60 secs of walking or alternative (intensity of 7-9 on the 0-10 RPE) interspersed by 60 secs of walking or cycling at low intensity recovery (RPE 3-5).


Experimental: High-intensity resistance training (HIRT) Behavioral: High-Intensity resistance training (HIRT)

Supervised HIRT sessions (2x/week) will comprise 2-3 sets of 6-8 repetitions progressively achieving 85% of 1RM.

Unsupervised HIRT sessions (1x/week) will involve 2-3 sets of 15-20 repetitions using a resistance exercise band when necessary.


No Intervention: Usual care (UC)
Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors



Primary Outcome Measures :
  1. Recruitment rate (feasibility target: ≥25% of eligible patients) [ Time Frame: Initiation through end of study recruitment at 26 months ]
    Percent of consenting participants relative to the total number of eligible participants approached

  2. Attendance rate (feasibility target: ≥70% to facility-based sessions) [ Time Frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization ]
    Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions

  3. Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions) [ Time Frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization ]
    Percent of completed repetitions relative to the total number of prescribed repetitions

  4. Retention rate (feasibility target: 70% of participants consented to study) [ Time Frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization ]
    Percent of participants that completed the study relative to the total number of participants consented to the study


Secondary Outcome Measures :
  1. Changes in cardiorespiratory fitness [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)

  2. Changes in musculoskeletal strength [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    1 repetition maximum (1RM) will be assessed for upper (e.g., seated row and chest press) and lower body (e.g., leg press)

  3. Changes in circulating cytokines [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples

  4. Changes in circulating growth factors [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Insulin-like growth factor-1 (IGF-1) and insulin-like binding protein 3 (IGFBP-3) will be assessed using blood samples

  5. Body composition [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Body mass will be measured using a weight scale (kg)

  6. Changes in waist circumference [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Waist circumference will be measured using a measuring tape (cm)

  7. Changes in body fat and lean body mass [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    % body fat and % lean body mass will be measured using a bioelectrical impedance analysis (BIA) scale

  8. Changes in Quality of Life [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)

  9. Anxiety [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

  10. Fear of disease progression [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Fear of disease progression will be measured using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF)

  11. Physical activity status [ Time Frame: At baseline and 8 weeks (post-intervention) ]
    Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older;
  • initiating or currently on AS for PCa;
  • not currently engaging in high-intensity aerobic and/or resistance training at 85%HRmax or ≥9 RPE in the Borg 0-10 RPE scale;
  • willing and able to travel to the study-designated facilities;
  • proficient in English;
  • able to provide written informed consent;
  • pass the screening CPET by achieving volitional exhaustion (rate of perceived exertion (RPE) ≥ 9 using the Borg 0-10 RPE scale) in the absence of any cardiorespiratory abnormalities.

Exclusion Criteria:

  • uncontrolled hypertension (≥2/3 of readings of > 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not;
  • been diagnosed with congestive heart failure (New York Heart Association Class II, III or IV);
  • a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI);
  • a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient;
  • a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol;
  • serious or non-healing wound, ulcer, or bone fracture;
  • experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living;
  • ongoing restriction of physical activity;
  • developed chest pain in the past month

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): NCT04266262


Locations
Layout table for location information
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 2W6
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Layout table for additonal information
Responsible Party: Daniel Santa Mina, PhD, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04266262    
Other Study ID Numbers: 16-6340
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data of this study will be available from the corresponding author upon reasonable request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Santa Mina, PhD, University of Toronto:
Active Surveillance
Prostate Cancer
High-intensity interval training
Resistance training
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases