Overview

This trial is active, not recruiting.

Conditions low anterior resection syndrome, rectal cancer
Treatment intra-rectal botulinum toxin a injection
Phase phase 2
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator Allergan
Start date May 2012
End date October 2015
Trial size 23 participants
Trial identifier NCT01589471, CE 11.088

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intra-rectal (or intra-colic) injection of 100 U of Botox-A
intra-rectal botulinum toxin a injection 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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Carole S Richard, MD FCRSC
Description No more information desired
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).