Back to resultsThe Value of Botox-A for Management of Low Anterior Resection Syndrome
Primary Purpose
Low Anterior Resection Syndrome, Rectal Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
intra-rectal Botulinum toxin A injection
Sponsored by
About this trial
This is an interventional treatment trial for Low Anterior Resection Syndrome focused on measuring Low anterior resection syndrome, Botulinum toxin A, Quality of life, Incontinence, Rectal cancer, Anorectal manometry
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier Universitaire de Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botox-A
Arm Description
Intra-rectal (or intra-colic) injection of 100 U of Botox-A
Outcomes
Primary Outcome Measures
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Secondary Outcome Measures
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with a visual scale for tenesmus and completeness of stool evacuation
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
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
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings
Long term efficacy of intra-rectal Botox-A injection on anorectal function as documented with Wexner score, EORTC-QLQ questionnaire and visual scale
Safety of intra-rectal Botox-A injections as documented with adverse events monitoring
Full Information
NCT ID
NCT01589471
First Posted
April 27, 2012
Last Updated
February 9, 2018
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01589471
Brief Title
The Value of Botox-A for Management of Low Anterior Resection Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome, Rectal Cancer
Keywords
Low anterior resection syndrome, Botulinum toxin A, Quality of life, Incontinence, Rectal cancer, Anorectal manometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox-A
Arm Type
Experimental
Arm Description
Intra-rectal (or intra-colic) injection of 100 U of Botox-A
Intervention Type
Drug
Intervention Name(s)
intra-rectal Botulinum toxin A injection
Other Intervention Name(s)
Botox (Allergan)
Intervention Description
intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
Primary Outcome Measure Information:
Title
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Time Frame
1 month
Title
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Title
Efficacy of intra-rectal Botox-A injection on quality of life as documented with EORTC-QlQ standardized questionnaires
Description
EORTC-QIQ is a quality of life questionnaire
Time Frame
1 month and 3 months
Title
Efficacy of intra-rectal Botox-A injection as documented with a patient medicine calender
Description
patient-filled calender for usage of any medication intended for symptomatic treatment of LARS
Time Frame
1 month
Title
Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings
Time Frame
1 month
Title
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
Title
Safety of intra-rectal Botox-A injections as documented with adverse events monitoring
Time Frame
1 month, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole S Richard, MD FCRSC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Value of Botox-A for Management of Low Anterior Resection Syndrome
We'll reach out to this number within 24 hrs