Clinical trial NCT02538913: Exercise Training for Rectal Cancer Patients
Official title: Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Exercise
Pelvic floor
Prehabilitation
Fecal incontinence
Urinary incontinence
Sexual dysfunction, physiological
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-09-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment.

In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.


Eligibility criteria: Inclusion Criteria:

* Cancer recti
* Planned curative LAR with preoperative radiotherapy
* Cancer stadium I-III
* Able to speak and understand Norwegian

Exclusion Criteria:

* Previous radiotherapy
* Previous pelvic surgery
* Diseases affecting the anal sphincter

Primary outcomes:
measure: Anal incontinence
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Anal incontinence
timeFrame: 12 months post surgery
measure: Urinary incontinence
timeFrame: 3 and 12 months post surgery
measure: Bowel dysfunction
timeFrame: 3 and 12 months post surgery
measure: Physiology of the anal sphincter
timeFrame: 3 and 12 months post surgery
measure: Sexual dysfunction
timeFrame: 3 and 12 months post surgery
measure: Quality of life
timeFrame: 3 and 12 months post surgery
measure: Maximal oxygen uptake (VO2max)
timeFrame: On an average 1 week pre surgery
measure: Postoperative complications
timeFrame: Up to five years post surgery
measure: Physical activity level
timeFrame: On an average 1 week pre surgery and three months post surgery
measure: In-hospital time
timeFrame: Up to 12 months post surgery
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Public Health and General Practice
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, PhD, MD
role: STUDY_DIRECTOR
References: