Clinical trial NCT04266262: High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
Official title: High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Active Surveillance
Prostate Cancer
High-intensity interval training
Resistance training
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2020-02-12
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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

Primary outcomes:
measure: Recruitment rate (feasibility target: ≥25% of eligible patients)
timeFrame: Initiation through end of study recruitment at 26 months
measure: Attendance rate (feasibility target: ≥70% to facility-based sessions)
timeFrame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
measure: Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions)
timeFrame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
measure: Retention rate (feasibility target: 70% of participants consented to study)
timeFrame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Secondary outcomes:
measure: Changes in cardiorespiratory fitness
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in musculoskeletal strength
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in circulating cytokines
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in circulating growth factors
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Body composition
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in waist circumference
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in body fat and lean body mass
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Changes in Quality of Life
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Anxiety
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Fear of disease progression
timeFrame: At baseline and 8 weeks (post-intervention)
measure: Physical activity status
timeFrame: At baseline and 8 weeks (post-intervention)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
citation: Papadopoulos E, Gillen J, Moore D, Au D, Kurgan N, Klentrou P, Finelli A, Alibhai SMH, Santa Mina D. High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Appl Physiol Nutr Metab. 2021 Dec;46(12):1535-1544. doi: 10.1139/apnm-2021-0365. Epub 2021 Aug 11.