Efficacy of Ondansetron in LARS Treatment

Rectal Cancer Clinical Trial

— Hodolar  

Official title:

Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182179
• Other study ID #: ORL-CHIR-001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: November 19, 2021

Study information

• Verified date: October 2022
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). It will be one week of washout between the two treatments.

During the treatment questionnaires will be completed by the patients to evaluate the efficacy of the study treatment and the quality of live.

Description:

This is a multi-centre randomized, double-blind, placebo-controlled, cross-over study aimed at testing the efficacy of Ondansetron in the low anterior resection syndrome (LARS) occurring as a consequence of surgery for rectal cancer.

Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). Neither the investigator nor the patient will be aware of the sequence (O-P or P-O) assigned to the patient. One week will elapse between the end of the first treatment and start of the second treatment.

The hypothesis to be tested is that 4 weeks of oral Ondansetron at the dose of 4mg BID induce a variation of the LARS Score at least 7 points (20%) greater than the variation occurring after 4 weeks of placebo.

The sample size calculated for the primary analysis is 38 evaluable patients. Considering an expected attrition rate of about 20%, it is expected to enrol approximately 46 patients in total.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Patients willing and able to comply with the study procedures

• Female patients of childbearing potential must agree to use a reliable method of contraception

• Written informed consent Patients who have undergone low anterior resection (LAR) for rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy

• Presence of functioning anastomosis

• Presence of significant LARS symptoms assessed by LARS Score

Exclusion Criteria:

• Known hypersensitivity or allergy to Ondansetron

• Previous Ondansetron antiemetic therapy completed less than 4 weeks before study entry

• Antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry

• Congenital long Q-T syndrome

• Ongoing treatment with drugs causing prolongation of the Q-T interval

• Uncorrected hypokalemia or hypomagnesemia

• Women who are pregnant or breast feeding or are willing to become pregnant during the study

• Clinically significant concomitant disease states or anastomotic complications which could impair the ability of the patient to participate in the trial

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Ondansetron 4 MG
Ondansetron is taken orally BD
• Placebo
Placebo is taken orally BD

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne
Switzerland	Ospedale Regionale di Lugano, Civico e Italiano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LARS score	The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment	10 wks
Secondary	Vaizey (St. Mark's) score	Change in Vaizey (St. Mark's) Score assessed before and at the end of Ondansetron and placebo treatment	10 wks
Secondary	Irritable Bowel Syndrome-Quality of Life	Irritable Bowel Syndrome-Quality of Life (IBS-QoL) assessed before and at the end of Ondansetron and placebo treatment	10 wks