Ondansetron for Low Anterior Resection Syndrome after rectal cancer treatment

Phase 2

Conditions: ow anterior resection syndrome following rectal cancer treatment
Digestive System
Postprocedural complications and disorders of the digestive system

Registration Number: ISRCTN48772765

Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 134

Inclusion Criteria

1. Aged =18 years
2. Previously undergone standard total mesorectal excision (TME) resection with, or without, neoadjuvant chemoradiotherapy (CRT) for pT0-4, N0-2, M0 rectal cancer
3. =1 year after the end of any chemoradiotherapy and surgical treatment (ileostomy closure or primary resection if a stoma was not performed)
4. No evidence of rectal cancer recurrence
5. LARS questionnaire symptom score of =21 (minor or major LARS)
6. LARS symptoms to include both of the following:
6.1. Presence of =4 bowel movements per day on average during the 14 days prior to the baseline visit
6.2. Moderate, severe or very severe faecal urgency (unable to delay bowel movements by 10 min or more) on =4 days during the 14 days prior to the baseline visit
7. LARS symptoms not adequately controlled by current treatment
7. For participants of childbearing potential, or their partners, agreement to use medically accepted contraception (e.g. oral contraceptive and condom, Intra-uterine device (IUD) and condom, or diaphragm with spermicide and condom) for the duration of study treatment and for at least 30 days afterwards for women, and 90 days afterwards for men.
8. Able to read and understand questionnaires in English
9. Written informed consent provided

Exclusion Criteria

1. Clinical and radiological anastomotic leakage after rectal cancer surgery, defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments
2. Gastrectomy
3. Other known organic GI diseases (e.g. Crohn’s disease, ulcerative colitis, coeliac disease)
4. Untreated thyroid dysfunction
5. Taking other medications influencing colonic motility (e.g. opioids, cholinergic agents, prokinetics, metoclopramide, cisapride, etc.) which are likely to be stopped or changed during the course of the trial
6. Lactose intolerance
7. Known QTc interval =450 ms for men and =470 ms for women
8. Continuous use of ondansetron for >1 month within the past year
9. Contraindications to ondansetron (e.g. concomitant use with apomorphine, hypersensitivity to any component of the preparation, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption)
10. Currently participating in any interventional phase of another clinical trial
11. Pregnant or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of days with no or mild urgency over the last 14 days of the planned 6 week treatment period measured using participant report in a daily diary between baseline and 6 weeks. Participants will record whether or not they had a bowel movement with urgency that day (yes or no), and those who responded yes will score their most urgent bowel movement that day as one of the following: mild (time able to delay bowel movement =10 mins), moderate (time able to delay bowel movement =5 to <10 mins), severe (time able to delay bowel movement =1 to <5 mins), or very severe (time able to delay bowel movement <1 min).

Secondary Outcome Measures