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Efficacy of Ondansetron in LARS Treatment (Hodolar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182179
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ente Ospedaliero Cantonale, Bellinzona

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Ondansetron 4 MG Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: O-P sequence
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
Ondansetron is taken orally BD

Drug: Placebo
Placebo is taken orally BD

Experimental: P-O sequence
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
Ondansetron is taken orally BD

Drug: Placebo
Placebo is taken orally BD




Primary Outcome Measures :
  1. Change in LARS score [ Time Frame: 10 wks ]
    The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment


Secondary Outcome Measures :
  1. Vaizey (St. Mark's) score [ Time Frame: 10 wks ]
    Change in Vaizey (St. Mark's) Score assessed before and at the end of Ondansetron and placebo treatment

  2. Irritable Bowel Syndrome-Quality of Life [ Time Frame: 10 wks ]
    Irritable Bowel Syndrome-Quality of Life (IBS-QoL) assessed before and at the end of Ondansetron and placebo treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182179


Contacts
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Contact: Dimitri Christoforidis, Prof. +41 (0)91 811 69 56 dimitri.christoforidis@eoc.ch

Locations
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Switzerland
CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Seraina Faes, MD    +41 (0)79 55 67502    seraina.faes@chuv.ch   
Ospedale Regionale di Lugano, Civico e Italiano Recruiting
Lugano, Switzerland, 6900
Contact: Dimitri Christoforidis, Prof.    +41 (0)91 811 69 56    dimitri.christoforidis@eoc.ch   
Sponsors and Collaborators
Ente Ospedaliero Cantonale, Bellinzona
Investigators
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Study Director: Dimitri Christoforidis, Prof. Ospedale Regionale di Lugano, Civico e Italiano
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Responsible Party: Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT03182179    
Other Study ID Numbers: ORL-CHIR-001
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents