Efficacy of Ondansetron in LARS Treatment

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Treatments: Ondansetron

Criteria

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.