Efficacy of Ondansetron in LARS Treatment

NCT03182179 | Completed

• 1 other identifier: ORL-CHIR-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Change in LARS score

  The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment

  10 wks

Secondary Outcomes (2)

• Vaizey (St. Mark's) score

  10 wks

• Irritable Bowel Syndrome-Quality of Life

  10 wks

Study Arms (2)

O-P sequence

EXPERIMENTAL

Patients will receive of oral Ondansetron 4mg BD for 28 days followed by 28 days of placebo. It will be one week of washout between the two treatments.

Drug: Ondansetron 4 MG; Drug: Placebo

P-O sequence

EXPERIMENTAL

Patients will receive oral placebo for 28 days followed by Ondansetron 4mg BD for 28 days. It will be one week of washout between the two treatments.

Drug: Ondansetron 4 MG; Drug: Placebo

Interventions

Ondansetron 4 MG DRUG

Ondansetron is taken orally BD

O-P sequence; P-O sequence

Placebo DRUG

Placebo is taken orally BD

O-P sequence; P-O sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (2)

CHUV

Lausanne, 1011, Switzerland

Location

Ospedale Regionale di Lugano, Civico e Italiano

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Dimitri Christoforidis, Prof.

  Ospedale Regionale di Lugano, Civico e Italiano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: November 1, 2016
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)