Exercise Training for Rectal Cancer Patients

Not Applicable

Terminated

• Conditions: Rectal Neoplasms

• Registration Number: NCT02538913
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-02
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anal incontinence	3 months post surgery	St. Marks score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Public Health and General Practice; 🇳🇴 Trondheim, Norway