Clinical trial · Interventional
Efficacy of Ondansetron in LARS Treatment
Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ondansetron 4 MG | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- O-P sequence
- description
- 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.
- interventionNames
- Drug: Ondansetron 4 MG
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- P-O sequence
- description
- 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.
- interventionNames
- Drug: Ondansetron 4 MG
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in LARS score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available