Low Anterior Resection SyndromePhase 2NCT01589471
The Value of Botox-A for Management of Low Anterior Resection Syndrome
A Phase 2 study testing intra-rectal Botulinum toxin A injection in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Anterior Resection Syndrome, Rectal Cancer
- What is being tested?
- intra-rectal Botulinum toxin A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Nov 2015
- Phase
- Phase 2
- 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
- Age 18 years or older
- Aptitude to sign informed consent
- Diagnosis of low anterior resection syndrome (LARS) : More than 12 months after sphincter-preserving surgery for treatment of locally advanced rectal cancer, Mild to moderate underwear soiling, Baseline Wexner score ranging from 0-16 (moderate symptoms, and Patient-reported imperious defecation or Patient-reported incomplete stool evacuation
- Digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus considering prior radical rectal surgery.
- Willingness to complete questionnaires and manometric studies before and after Botox-A administration
- Prior failed medical treatment, at least one attempt (narcotics, loperamide, cholestyramine, fibers)
Who cannot join
- Inability to sign informed consent
- Counter-indication to Botox-A administration : Allergy to Botox-A or its ingredients (Clostridium botulinum type A neurotoxin complex, human albumin and sodium chloride, Allergy to other forms of botulinum toxin (Dysport, Xeomin or Myobloc, Myasthenia gravis, Eaton-Lambert syndrome, lateral amyotrophic sclerosis or any other neurological disease which might interfere with neuromuscular function
- Prior use of any form of botulinum toxin A, for any indication
- Infection at proposed Botox-A injection site
- Personal or family history of bleeding diathesis
- Pregnancy or breastfeeding
- Severe incontinence (Wexner score ≥ 17 or daily use of diapers)
- Patient taking anticoagulant. ASA ( acetylsalicylic acid) allowed
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, H2X 3J4
About this study
Official title: The Value of Botox-A Administered as a Single Intra-rectal Injection for the Management of Low Anterior Resection Syndrome: A Phase II Study
Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases.
One possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. These include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery.
Read more
Current available treatments are often ineffective, highlighting the need for more successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. It is currently used for the treatment of various smooth muscle spastic diseases.
The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical treatment alternative for LARS. The goal of this study is to document the effects of intra-rectal BTX-A injections on sphincter function and quality of life of patients with LARS.
Read the detailed description
No more information desired
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Being tested
- intra-rectal Botulinum toxin A injection
- Keywords
- Low anterior resection syndrome, Botulinum toxin A, Quality of life, Incontinence, Rectal cancer, Anorectal manometry
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-rectal Botulinum toxin A injectionDrug
Also called Botox (Allergan)
intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Botox-A | Experimental | Intra-rectal (or intra-colic) injection of 100 U of Botox-A Receives: Drug: intra-rectal Botulinum toxin A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Measured: 1 month
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Measured: 3 months
Secondary outcomes (6)
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with a visual scale for tenesmus and completeness of stool evacuation
Measured: 1 month and 3 months
Efficacy of intra-rectal Botox-A injection on quality of life as documented with EORTC-QlQ standardized questionnaires
EORTC-QIQ is a quality of life questionnaire
Measured: 1 month and 3 months
Efficacy of intra-rectal Botox-A injection as documented with a patient medicine calender
patient-filled calender for usage of any medication intended for symptomatic treatment of LARS
Measured: 1 month
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings
Measured: 1 month
Long term efficacy of intra-rectal Botox-A injection on anorectal function as documented with Wexner score, EORTC-QLQ questionnaire and visual scale
Measured: 6 months
Safety of intra-rectal Botox-A injections as documented with adverse events monitoring
Measured: 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Carole S Richard, MD FCRSC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589471
- Sponsor's protocol ID
- CE 11.088
- Status last verified
- May 2015
- First submitted
- 27 Apr 2012
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Botox-A Administered as a Single Intra-rectal Injection for the Management of Low Anterior Resection Syndrome: A Phase II Study
- ClinicalTrials.gov ID
- NCT01589471
- Acronym / sponsor ID
- CE 11.088
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Keywords
- Low anterior resection syndrome, Botulinum toxin A, Quality of life, Incontinence, Rectal cancer, Anorectal manometry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Allergan
- Study start
- May 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 May 2012 (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.
Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases.
One possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. These include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery.
Current available treatments are often ineffective, highlighting the need for more successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. It is currently used for the treatment of various smooth muscle spastic diseases.
The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical treatment alternative for LARS. The goal of this study is to document the effects of intra-rectal BTX-A injections on sphincter function and quality of life of patients with LARS.
Detailed description
No more information desired
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox-A | Experimental | Drug: intra-rectal Botulinum toxin A injectionIntra-rectal (or intra-colic) injection of 100 U of Botox-A |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Aptitude to sign informed consent
- Diagnosis of low anterior resection syndrome (LARS) : More than 12 months after sphincter-preserving surgery for treatment of locally advanced rectal cancer, Mild to moderate underwear soiling, Baseline Wexner score ranging from 0-16 (moderate symptoms, and Patient-reported imperious defecation or Patient-reported incomplete stool evacuation
- Digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus considering prior radical rectal surgery.
- Willingness to complete questionnaires and manometric studies before and after Botox-A administration
Key exclusion criteria (8 listed)
- Inability to sign informed consent
- Counter-indication to Botox-A administration : Allergy to Botox-A or its ingredients (Clostridium botulinum type A neurotoxin complex, human albumin and sodium chloride, Allergy to other forms of botulinum toxin (Dysport, Xeomin or Myobloc, Myasthenia gravis, Eaton-Lambert syndrome, lateral amyotrophic sclerosis or any other neurological disease which might interfere with neuromuscular function
- Prior use of any form of botulinum toxin A, for any indication
- Infection at proposed Botox-A injection site
- Personal or family history of bleeding diathesis
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 |
|---|---|---|
| intra-rectal Botulinum toxin A injectionAlso: Botox (Allergan)intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis | Drug | Botox-A |
Primary outcome
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Time frame: 1 month
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Time frame: 3 months
6 secondary outcomes
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with a visual scale for tenesmus and completeness of stool evacuation
Time frame: 1 month and 3 months
Efficacy of intra-rectal Botox-A injection on quality of life as documented with EORTC-QlQ standardized questionnaires
Time frame: 1 month and 3 months
Efficacy of intra-rectal Botox-A injection as documented with a patient medicine calender
Time frame: 1 month
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings
Time frame: 1 month
Long term efficacy of intra-rectal Botox-A injection on anorectal function as documented with Wexner score, EORTC-QLQ questionnaire and visual scale
Time frame: 6 months
Safety of intra-rectal Botox-A injections as documented with adverse events monitoring
Time frame: 1 month, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
Carole S Richard, MD FCRSC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intra-rectal Botulinum toxin A injection in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 12 Feb 2018. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score (time frame: 1 month). The study lists 2 primary outcomes in all. 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 12 Feb 2018.