Rectal CancerHodolarNCT03182179
Efficacy of Ondansetron in LARS Treatment
A study testing Ondansetron 4 MG in people with Rectal Cancer, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Ondansetron 4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2016to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
CHUV
Lausanne, 1011
Ospedale Regionale di Lugano, Civico e Italiano
Lugano, 6900
About this study
Official title: Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Ondansetron 4 MG, Placebo
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MGDrug
Ondansetron is taken orally BD
PlaceboDrug
Placebo is taken orally BD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ondansetron 4 MG; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LARS score
The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment
Measured: 10 wks
Secondary outcomes (2)
Vaizey (St. Mark's) score
Change in Vaizey (St. Mark's) Score assessed before and at the end of Ondansetron and placebo treatment
Measured: 10 wks
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
Measured: 10 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Nov 2016
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri Christoforidis, Prof., Study director, Ospedale Regionale di Lugano, Civico e Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182179
- Sponsor's protocol ID
- ORL-CHIR-001
- Acronym
- Hodolar
- Status last verified
- Oct 2022
- First submitted
- 7 Jun 2017
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03182179
- Acronym / sponsor ID
- Hodolar / ORL-CHIR-001
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O-P sequence | Experimental | Drug: Ondansetron 4 MG, Drug: PlaceboPatients 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. |
| P-O sequence | Experimental | Drug: Ondansetron 4 MG, Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 4 MGOndansetron is taken orally BD | Drug | O-P sequence, P-O sequence |
| PlaceboPlacebo is taken orally BD | Drug | O-P sequence, P-O sequence |
Primary outcome
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
2 secondary outcomes
Vaizey (St. Mark's) score
Time frame: 10 wks
Irritable Bowel Syndrome-Quality of Life
Time frame: 10 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
Active, not recruitingPhase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Not yet recruiting
Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Colorectal Cancer (CRC) Screening, CRC Screening
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Christoforidis, Prof. study director
Ospedale Regionale di Lugano, Civico e Italiano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron 4 MG in people with Rectal Cancer, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LARS score (time frame: 10 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.