Rectal Neoplasms
Conditions
Keywords
Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological
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.
Interventions
Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal incontinence | 3 months post surgery | St. Marks score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary incontinence | 3 and 12 months post surgery | International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF) |
| Bowel dysfunction | 3 and 12 months post surgery | Low anterior resection syndrome score (LARS) |
| 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 |
| Anal incontinence | 12 months post surgery | St. Marks score |
| Maximal oxygen uptake (VO2max) | On an average 1 week pre surgery | Cardiopulmonary exercise test |
| 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 |
| In-hospital time | Up to 12 months post surgery | Number of days in hospital from the patient records |
| 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). |
Countries
Norway