Exercise Training for Rectal Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Behavioral: Exercise training
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Patients randomized to the exercise training group will be individually instructed in correct pelvic floor muscle contractions and intensive pelvic floor muscle training to perform daily. In addition they will be encouraged to exercise regularly ≥3 days/week. The exercise program will be individualized and consisting of both aerobic and strength exercise training. | Behavioral: Exercise training<br>* Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.<br>Procedure: Usual care<br>* Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training<br>|
| Active Comparator: Usual care<br>Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training | Procedure: Usual care<br>* Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal incontinence | St. Marks score | 3 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal incontinence | St. Marks score | 12 months post surgery | 
| Urinary incontinence | International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF) | 3 and 12 months post surgery | 
| Bowel dysfunction | Low anterior resection syndrome score (LARS) | 3 and 12 months post surgery | 
| Physiology of the anal sphincter | Anal manometry | 3 and 12 months post surgery | 
| Sexual dysfunction | The International Index of Erectile Function (IIEF) for men and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (PISQ-IR) for women | 3 and 12 months post surgery | 
| Quality of life | The European Organization for Research and Treatment of Cancer Quality of Life core questionnaire (EORTC QLQ-C30) and the colorectal cancer specific Quality of Life Questionnaire (QLQ-C38). | 3 and 12 months post surgery | 
| Maximal oxygen uptake (VO2max) | Cardiopulmonary exercise test | On an average 1 week pre surgery | 
| Postoperative complications | International Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records | Up to five years post surgery | 
| Physical activity level | Activity monitor (SenseWear) to measure level of daily physical activity | On an average 1 week pre surgery and three months post surgery | 
| In-hospital time | Number of days in hospital from the patient records | Up to 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological