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Exercise Training for Rectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02538913
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Rectal Neoplasms Behavioral: Exercise training Procedure: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
Actual Study Start Date : September 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Anal incontinence [ Time Frame: 3 months post surgery ]
    St. Marks score


Secondary Outcome Measures :
  1. Anal incontinence [ Time Frame: 12 months post surgery ]
    St. Marks score

  2. Urinary incontinence [ Time Frame: 3 and 12 months post surgery ]
    International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)

  3. Bowel dysfunction [ Time Frame: 3 and 12 months post surgery ]
    Low anterior resection syndrome score (LARS)

  4. Physiology of the anal sphincter [ Time Frame: 3 and 12 months post surgery ]
    Anal manometry

  5. Sexual dysfunction [ Time Frame: 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

  6. Quality of life [ Time Frame: 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).

  7. Maximal oxygen uptake (VO2max) [ Time Frame: On an average 1 week pre surgery ]
    Cardiopulmonary exercise test

  8. Postoperative complications [ Time Frame: 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

  9. Physical activity level [ Time Frame: On an average 1 week pre surgery and three months post surgery ]
    Activity monitor (SenseWear) to measure level of daily physical activity

  10. In-hospital time [ Time Frame: Up to 12 months post surgery ]
    Number of days in hospital from the patient records



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538913


Contacts
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Contact: Signe N Stafne, PhD +47 480 71 766 signe.n.stafne@ntnu.no

Locations
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Norway
Department of Public Health and General Practice Recruiting
Trondheim, Norway, 7489
Contact: Signe N Stafne, PhD    +47 480 71 766    signe.n.stafne@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Siri Forsmo, PhD, MD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02538913     History of Changes
Other Study ID Numbers: 2014/2284
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Exercise
Pelvic floor
Prehabilitation
Fecal incontinence
Urinary incontinence
Sexual dysfunction, physiological
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases