search
Back to results

Efficacy of Ondansetron in LARS Treatment (Hodolar)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ondansetron 4 MG
Placebo
Sponsored by
Ente Ospedaliero Cantonale, Bellinzona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHUV
  • Ospedale Regionale di Lugano, Civico e Italiano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

O-P sequence

P-O sequence

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vaizey (St. Mark's) score
Change in Vaizey (St. Mark's) Score assessed before and at the end of Ondansetron and placebo treatment
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

Full Information

First Posted
June 7, 2017
Last Updated
October 14, 2022
Sponsor
Ente Ospedaliero Cantonale, Bellinzona
search

1. Study Identification

Unique Protocol Identification Number
NCT03182179
Brief Title
Efficacy of Ondansetron in LARS Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ente Ospedaliero Cantonale, Bellinzona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O-P sequence
Arm Type
Experimental
Arm 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.
Arm Title
P-O sequence
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 MG
Intervention Description
Ondansetron is taken orally BD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is taken orally BD
Primary Outcome Measure Information:
Title
Change in LARS score
Description
The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment
Time Frame
10 wks
Secondary Outcome Measure Information:
Title
Vaizey (St. Mark's) score
Description
Change in Vaizey (St. Mark's) Score assessed before and at the end of Ondansetron and placebo treatment
Time Frame
10 wks
Title
Irritable Bowel Syndrome-Quality of Life
Description
Irritable Bowel Syndrome-Quality of Life (IBS-QoL) assessed before and at the end of Ondansetron and placebo treatment
Time Frame
10 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Christoforidis, Prof.
Organizational Affiliation
Ospedale Regionale di Lugano, Civico e Italiano
Official's Role
Study Director
Facility Information:
Facility Name
CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano, Civico e Italiano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Ondansetron in LARS Treatment

We'll reach out to this number within 24 hrs