Exercise Training for Rectal Cancer Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Behavioral: Exercise training; Procedure: Usual care

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7489
    • Department of Public Health and General Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training; 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; Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.; Procedure: Usual care; Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
Active Comparator: Usual care; 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; Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Siri Forsmo, PhD, MD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Urinary incontinence; Fecal incontinence; Prehabilitation; Pelvic floor; Sexual dysfunction, physiological
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2014/2284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No