The Value of Botox-A for Management of Low Anterior Resection Syndrome
This study is currently recruiting participants.
Verified June 2011 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator:
Allergan
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01589471
First received: April 27, 2012
Last updated: May 23, 2012
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Anterior Resection Syndrome Rectal Cancer |
Drug: intra-rectal Botulinum toxin A injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):
Primary Outcome Measures:
- Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Efficacy of intra-rectal Botox-A injection as documented with a patient medicine calender [ Time Frame: 1 month ] [ Designated as safety issue: No ]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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Safety of intra-rectal Botox-A injections as documented with adverse events monitoring [ Time Frame: 1 month, 3 months and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 23 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botox-A
Intra-rectal (or intra-colic) injection of 100 U of Botox-A
|
Drug: intra-rectal Botulinum toxin A injection
intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
Other Name: Botox (Allergan)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 7-16 (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 allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589471
Contacts
| Contact: Carole S Richard, MD FCRSC | 514-890-8000 ext 35270 | carole.richard.chum@ssss.gouv.qc.ca |
Locations
| Canada, Quebec | |
| Centre Hospitalier Universitaire de Montréal | Recruiting |
| Montreal, Quebec, Canada, H2X 3J4 | |
| Contact: Richard 514-890-8000 ext 35270 | |
| Contact: Josette Bergeron, Nurse-Study coordinator 514-890-8000 ext 35817 | |
| Principal Investigator: Carole S Richard, MD FCRSC | |
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Allergan
Investigators
| Principal Investigator: | Carole S Richard, MD FCRSC | Centre hospitalier de l'Université de Montréal (CHUM) |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01589471 History of Changes |
| Other Study ID Numbers: | CE 11.088 |
| Study First Received: | April 27, 2012 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
Low anterior resection syndrome Botulinum toxin A Quality of life |
Incontinence Rectal cancer Anorectal manometry |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013