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Exercise Training for Rectal Cancer Patients

Primary Purpose

Rectal Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise training
Usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Neoplasms focused on measuring Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Public Health and General Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise training

Usual care

Arm Description

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.

Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training

Outcomes

Primary Outcome Measures

Anal incontinence
St. Marks score

Secondary Outcome Measures

Anal incontinence
St. Marks score
Urinary incontinence
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)
Bowel dysfunction
Low anterior resection syndrome score (LARS)
Physiology of the anal sphincter
Anal manometry
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
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).
Maximal oxygen uptake (VO2max)
Cardiopulmonary exercise test
Postoperative complications
International Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records
Physical activity level
Activity monitor (SenseWear) to measure level of daily physical activity
In-hospital time
Number of days in hospital from the patient records

Full Information

First Posted
August 26, 2015
Last Updated
November 13, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02538913
Brief Title
Exercise Training for Rectal Cancer Patients
Official Title
Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
too slow recruitment; lack of resources
Study Start Date
September 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
Primary Outcome Measure Information:
Title
Anal incontinence
Description
St. Marks score
Time Frame
3 months post surgery
Secondary Outcome Measure Information:
Title
Anal incontinence
Description
St. Marks score
Time Frame
12 months post surgery
Title
Urinary incontinence
Description
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)
Time Frame
3 and 12 months post surgery
Title
Bowel dysfunction
Description
Low anterior resection syndrome score (LARS)
Time Frame
3 and 12 months post surgery
Title
Physiology of the anal sphincter
Description
Anal manometry
Time Frame
3 and 12 months post surgery
Title
Sexual dysfunction
Description
The International Index of Erectile Function (IIEF) for men and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (PISQ-IR) for women
Time Frame
3 and 12 months post surgery
Title
Quality of life
Description
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).
Time Frame
3 and 12 months post surgery
Title
Maximal oxygen uptake (VO2max)
Description
Cardiopulmonary exercise test
Time Frame
On an average 1 week pre surgery
Title
Postoperative complications
Description
International Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records
Time Frame
Up to five years post surgery
Title
Physical activity level
Description
Activity monitor (SenseWear) to measure level of daily physical activity
Time Frame
On an average 1 week pre surgery and three months post surgery
Title
In-hospital time
Description
Number of days in hospital from the patient records
Time Frame
Up to 12 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Forsmo, PhD, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Public Health and General Practice
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

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Exercise Training for Rectal Cancer Patients

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