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The Value of Botox-A for Management of Low Anterior Resection Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
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: January 28, 2014
Last verified: January 2014
  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 ]
    EORTC-QIQ is a quality of life questionnaire

  • 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: March 2014
Estimated Primary Completion Date: March 2014 (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)

Detailed Description:

No more information desired

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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: January 28, 2014
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:
Syndrome
Disease
Pathologic Processes
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014