Clinical trial NCT02036684: Prehabilitation for Prostate Cancer Surgery
Official title: A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy
Keywords: Prostate cancer
Radical prostatectomy
Prehabilitation
Pelvic floor muscle exercises
Lead sponsor: University of Guelph-Humber
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Princess Margaret Hospital, Canada
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2014-01-15
Enrollment: 86
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.


Eligibility criteria: Inclusion Criteria:

* Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
* between the ages of 40 and 80 years.

Exclusion Criteria:

* i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
* ii) significant congestive heart failure (New York Heart Association class III or greater);
* iii) uncontrolled pain;
* iv) neurological or musculoskeletal co-morbidity inhibiting exercise;
* v) diagnosed psychotic, addictive, or major cognitive disorders;
* vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP \> 140 mmHg; DBP \> 90 mmHg), known dyslipidemia, known impaired fasting, glucose (\>110 mg/dL), obesity (BMI \> 30 kg/m2 or waist circumference \> 102cm), or physically inactive (\<150 min of moderate intensity physical activity per week).

Primary outcomes:
measure: Recruitment
timeFrame: When recruitment is complete (approximately 12 months after study initiation; January 2015)
measure: Adherence to Prehabilitation Program
timeFrame: 26 weeks postoperatively
measure: Contamination
timeFrame: 26 weeks postoperatively
measure: Study Retention
timeFrame: 26 weeks postoperatively
Secondary outcomes:
measure: Physical Fitness
timeFrame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
measure: Quality of Life
timeFrame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
measure: Psychosocial Wellbeing
timeFrame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
measure: Physical Activity
timeFrame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
measure: Treatment Complications
timeFrame: 26 weeks postoperatively
measure: Length of stay
timeFrame: From time of surgery to discharge (typically 1 week)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References:
citation: Au D, Matthew AG, Lopez P, Hilton WJ, Awasthi R, Bousquet-Dion G, Ladha K, Carli F, Santa Mina D. Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT. Sports Med Open. 2019 May 22;5(1):18. doi: 10.1186/s40798-019-0191-2.
citation: Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.