NauseaPhase 2NCT02388750
Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
A Phase 2 study testing Palonosetron and Low or moderate risk radiotherapy in people with Nausea and Vomiting, run by Dr. Edward Chow at 1 site in Canada.
Trial summary
This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Palonosetron and Low or moderate risk radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 7 Aug 2017
- Phase
- Phase 2
- 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
- Informed consent
- Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.
- Patients will be grouped according to nausea and vomiting status at baseline as follows:
- Group 1: Patient is experiencing no nausea and vomiting at baseline
- Group 2: Patient is experiencing at least mild nausea and/or at least mild vomiting at baseline
Who cannot join
- Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
- Patient received cranial RT within 7 days prior to commencement of protocol RT.
- Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
- Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
- Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
- Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties during or within 10 days following completion of protocol RT.
Show all 10Show fewer
- Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose corticosteroids (hydrocortisone) are used for cancer treatment
- Patient is allergic to protocol medication.
- Patient has a Karnofsky Performance Status score <40.
- Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
Official title: Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.
- Being tested
- Palonosetron, Low or moderate risk radiotherapy
- Keywords
- nausea, vomiting, radiation, anti-emetic drug
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
Low or moderate risk radiotherapyRadiation
Low or moderately emetogenic radiotherapy will be given to all patients on study.
| Study group | Role | What they receive |
|---|---|---|
| No previous nausea and vomiting | Other | Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
No previous nausea and vomiting 24 hours prior to radiotherapy Receives: Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy |
| Previous nausea and/or vomiting | Other | Palonosetron 0.5 mg oral capsule given for the length of radiation treatment
Previous nausea and/or vomiting 24 hours prior to radiotherapy Receives: Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy. Daily diary collects events of nausea and/or vomiting, and corresponding severity.
Measured: Day 0 to Day 10 post-radiation
Secondary outcomes (9)
Complete prophylaxis of nausea
Proportion of patients achieving complete prophylaxis of nausea and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy
Measured: Day 0 to Day 10 post-radiation
Complete prophylaxis of vomiting
Proportion of patients achieving complete prophylaxis of vomiting without requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy
Measured: Day 0 to Day 10 post-radiation
Partial control of nausea
Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy
Measured: Day 0 to Day 10 post-radiation
Partial control of vomiting
Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy
Measured: Day 0 to Day 10 post-radiation
Time to use of rescue medication
Median time from first fraction of radiation therapy to first use or increase in use of rescue medication
Measured: Day 0 to Day 10 post-radiation
Time to nausea
Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea
Measured: Day 0 to Day 10 post-radiation
Time to vomiting
Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting
Measured: Day 0 to Day 10 post-radiation
Quality of life
Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE.
Measured: Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
Adverse effects
The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria.
Measured: Day 0 to Day 10 post-radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Edward Chow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Edward Chow, Sunnybrook Health Sciences Centre
- Investigators
- Chow Edward, MBBS PhD, Principal investigator, Odette Cancer Centre, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388750
- Sponsor's protocol ID
- Palonosetron
- Status last verified
- Oct 2017
- First submitted
- 20 Feb 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
- ClinicalTrials.gov ID
- NCT02388750
- Acronym / sponsor ID
- Palonosetron
- Keywords
- nausea, vomiting, radiation, anti-emetic drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dr. Edward ChowUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No previous nausea and vomiting | Other | Drug: Palonosetron, Radiation: Low or moderate risk radiotherapyPalonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy |
| Previous nausea and/or vomiting | Other | Drug: Palonosetron, Radiation: Low or moderate risk radiotherapyPalonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.
- Patients will be grouped according to nausea and vomiting status at baseline as follows:
Key exclusion criteria (10 listed)
- Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
- Patient received cranial RT within 7 days prior to commencement of protocol RT.
- Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
- Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
- Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
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 |
|---|---|---|
| PalonosetronPalonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT | Drug | No previous nausea and vomiting, Previous nausea and/or vomiting |
| Low or moderate risk radiotherapyLow or moderately emetogenic radiotherapy will be given to all patients on study. | Radiation | No previous nausea and vomiting, Previous nausea and/or vomiting |
Primary outcome
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
Time frame: Day 0 to Day 10 post-radiation
Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy. Daily diary collects events of nausea and/or vomiting, and corresponding severity.
9 secondary outcomes
Complete prophylaxis of nausea
Time frame: Day 0 to Day 10 post-radiation
Complete prophylaxis of vomiting
Time frame: Day 0 to Day 10 post-radiation
Partial control of nausea
Time frame: Day 0 to Day 10 post-radiation
Partial control of vomiting
Time frame: Day 0 to Day 10 post-radiation
Time to use of rescue medication
Time frame: Day 0 to Day 10 post-radiation
Time to nausea
Time frame: Day 0 to Day 10 post-radiation
Time to vomiting
Time frame: Day 0 to Day 10 post-radiation
Quality of life
Time frame: Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
Adverse effects
Time frame: Day 0 to Day 10 post-radiation
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 6 Oct 2017.
Related trials for Nausea
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
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.
Chow Edward, MBBS PhD principal investigator
Odette Cancer Centre, Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron and Low or moderate risk radiotherapy in people with Nausea and Vomiting, run by Dr. Edward Chow at 1 site in Canada.
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 5 inclusion and 10 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy for prevention of nausea and vomiting events as measured by a daily diary (time frame: Day 0 to Day 10 post-radiation). 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 6 Oct 2017.