Rectal NeoplasmsNCT02538913
Exercise Training for Rectal Cancer Patients
A study testing Exercise training in people with Rectal Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Exercise training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer recti
- Planned curative LAR with preoperative radiotherapy
- Cancer stadium I-III
- Able to speak and understand Norwegian
Who cannot join
- Previous radiotherapy
- Previous pelvic surgery
- Diseases affecting the anal sphincter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rectal Neoplasms
- Being tested
- Exercise training, Usual care
- Keywords
- Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological
- Medical subject headings
- Rectal Neoplasms, Motor Activity, Fecal Incontinence, Urinary Incontinence, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.
Usual careProcedure or surgery
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 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. Receives: Behavioral: Exercise training; Procedure: Usual care |
| Usual care | Active comparator | Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal incontinence
St. Marks score
Measured: 3 months post surgery
Secondary outcomes (10)
Anal incontinence
St. Marks score
Measured: 12 months post surgery
Urinary incontinence
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)
Measured: 3 and 12 months post surgery
Bowel dysfunction
Low anterior resection syndrome score (LARS)
Measured: 3 and 12 months post surgery
Physiology of the anal sphincter
Anal manometry
Measured: 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
Measured: 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).
Measured: 3 and 12 months post surgery
Maximal oxygen uptake (VO2max)
Cardiopulmonary exercise test
Measured: 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
Measured: Up to five years post surgery
Physical activity level
Activity monitor (SenseWear) to measure level of daily physical activity
Measured: On an average 1 week pre surgery and three months post surgery
In-hospital time
Number of days in hospital from the patient records
Measured: Up to 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: too slow recruitment; lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, PhD, MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538913
- Sponsor's protocol ID
- 2014/2284
- Status last verified
- Nov 2020
- First submitted
- 26 Aug 2015
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02538913
- Acronym / sponsor ID
- 2014/2284
- Conditions
- Rectal Neoplasms
- Keywords
- Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too slow recruitment; lack of resources
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise training, Procedure: Usual carePatients 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. |
| Usual care | Active comparator | Procedure: Usual carePatients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer recti
- Planned curative LAR with preoperative radiotherapy
- Cancer stadium I-III
- Able to speak and understand Norwegian
Key exclusion criteria (3 listed)
- Previous radiotherapy
- Previous pelvic surgery
- Diseases affecting the anal sphincter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingDaily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week. | Behavioural | Exercise training |
| Usual carePatients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training | Procedure or surgery | Exercise training, Usual care |
Primary outcome
Anal incontinence
Time frame: 3 months post surgery
St. Marks score
10 secondary outcomes
Anal incontinence
Time frame: 12 months post surgery
Urinary incontinence
Time frame: 3 and 12 months post surgery
Bowel dysfunction
Time frame: 3 and 12 months post surgery
Physiology of the anal sphincter
Time frame: 3 and 12 months post surgery
Sexual dysfunction
Time frame: 3 and 12 months post surgery
Quality of life
Time frame: 3 and 12 months post surgery
Maximal oxygen uptake (VO2max)
Time frame: On an average 1 week pre surgery
Postoperative complications
Time frame: Up to five years post surgery
Physical activity level
Time frame: On an average 1 week pre surgery and three months post surgery
In-hospital time
Time frame: Up to 12 months post surgery
Results and safety
The study was stopped early (reason given: too slow recruitment; lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Forsmo, PhD, MD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Rectal Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: too slow recruitment; lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal incontinence (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.