Exercise Training for Rectal Cancer Patients

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02538913
• Other study ID #: 2014/2284
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 2020

Study information

• Verified date: November 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Public Health and General Practice	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal incontinence	St. Marks score	3 months post surgery
Secondary	Anal incontinence	St. Marks score	12 months post surgery
Secondary	Urinary incontinence	International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)	3 and 12 months post surgery
Secondary	Bowel dysfunction	Low anterior resection syndrome score (LARS)	3 and 12 months post surgery
Secondary	Physiology of the anal sphincter	Anal manometry	3 and 12 months post surgery
Secondary	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
Secondary	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
Secondary	Maximal oxygen uptake (VO2max)	Cardiopulmonary exercise test	On an average 1 week pre surgery
Secondary	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
Secondary	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
Secondary	In-hospital time	Number of days in hospital from the patient records	Up to 12 months post surgery