EmesisPhase 4ER11-02NCT01913990
Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.
A Phase 4 study testing Dexamethasone, Ondansetron, Aprepitant and Arm A: Standard Anti-emetic regimen in people with Emesis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Emesis
- What is being tested?
- Dexamethasone, Ondansetron, Aprepitant and Arm A: Standard Anti-emetic regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Dec 2017
- Phase
- Phase 4
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed invasive breast cancer (stage I-III)
- Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy;
- Able to consent and fill study forms
Who cannot join
- Received previous chemotherapy
- Symptoms of nausea or vomiting at baseline (disease related)
- On chronic anti-emetic therapy
- On daily corticosteroids prior to initiation of chemotherapy
- Allergic to steroids, 5HT3 or NK-1
- Uncontrolled diabetes
- Medical or psychiatric illness that would interfere with patients' ability to complete the diary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study
For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.
- Conditions
- Emesis
- Being tested
- Dexamethasone, Ondansetron, Aprepitant, Arm A: Standard Anti-emetic regimen
- Keywords
- Nausea, Vomiting
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone, Ondansetron, AprepitantDrug
Also called Decadron, Zofran, Emend
Arm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary.
Arm A: Standard Anti-emetic regimenOther
Treating physician's discretion for type of anti-emetic to be prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard Anti-emetic regimen | Other | The standard anti-emetic arm:
In this arm the treating medical oncologist will determine the choice of anti-emetic regimen that they perceive the patient would require and prescribe it. The treating physician will be blinded to result of the personalized composite emesis score. The physician may or may not choose to prescribe an NK-1 inhibitor as the study will not predetermine the type of anti-emetics used. In the event that the patient experienced chemo induced nausea and vomiting (CINV), modifications to the initial anti emetic regimen would be left to the treating physician. Receives: Other: Arm A: Standard Anti-emetic regimen |
| Arm B: Dexamethasone, Ondansetron, Aprepitant | Experimental | The emesis risk model arm:
Prior to the start of intravenous chemotherapy an emesis risk score will be calculated for both acute and delayed emesis. The anti-emetic prophylaxis treatment will follow the emesis risk score. Whereby either an acute emesis score of ≥7 and/or a delayed emesis score of >16 will be considered high-risk. The anti-emetics will be prescribed reflecting this risk for pre-chemotherapy, 8 hrs post chemotherapy and day 2-3 post chemotherapy. Dexamethasone, Ondansetron and Aprepitant will be given in different combination and doses depending on what score the participant receives based on their responses to the diary. For subsequent cycle the anti-emetic score will be re-calculated prior to each cycle and the choice of anti-emetics adjusted if necessary. Receives: Drug: Dexamethasone, Ondansetron, Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines.
Measured: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Secondary outcomes (1)
Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines.
Measured: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmesisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Clemons, Dr., Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913990
- Sponsor's protocol ID
- 2011348-01H
- Acronym
- ER11-02
- Status last verified
- Jan 2017
- First submitted
- 22 Jul 2013
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clemons M, Bouganim N, Smith S, Mazzarello S, Vandermeer L, Segal R, Dent S, Gertler S, Song X, Wheatley-Price P, Dranitsaris G. Risk Model-Guided Antiemetic Prophylaxis vs Physician's Choice in Patients Receiving Chemotherapy for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):225-31. doi: 10.1001/jamaoncol.2015.3730.
PubMed 26562292
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study
- ClinicalTrials.gov ID
- NCT01913990
- Acronym / sponsor ID
- ER11-02 / 2011348-01H
- Conditions
- Emesis
- Keywords
- Nausea, Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Aug 2013 (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.
For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard Anti-emetic regimen | Other | Other: Arm A: Standard Anti-emetic regimenThe standard anti-emetic arm: In this arm the treating medical oncologist will determine the choice of anti-emetic regimen that they perceive the patient would require and prescribe it. The treating physician will be blinded to result of the personalized composite emesis score. The physician may or may not choose to prescribe an NK-1 inhibitor as the study will not predetermine the type of anti-emetics used. In the event that the patient experienced chemo induced nausea and vomiting (CINV), modifications to the initial anti emetic regimen would be left to the treating physician. |
| Arm B: Dexamethasone, Ondansetron, Aprepitant | Experimental | Drug: Dexamethasone, Ondansetron, AprepitantThe emesis risk model arm: Prior to the start of intravenous chemotherapy an emesis risk score will be calculated for both acute and delayed emesis. The anti-emetic prophylaxis treatment will follow the emesis risk score. Whereby either an acute emesis score of ≥7 and/or a delayed emesis score of >16 will be considered high-risk. The anti-emetics will be prescribed reflecting this risk for pre-chemotherapy, 8 hrs post chemotherapy and day 2-3 post chemotherapy. Dexamethasone, Ondansetron and Aprepitant will be given in different combination and doses depending on what score the participant receives based on their responses to the diary. For subsequent cycle the anti-emetic score will be re-calculated prior to each cycle and the choice of anti-emetics adjusted if necessary. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed invasive breast cancer (stage I-III)
- Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy;
- Able to consent and fill study forms
Key exclusion criteria (7 listed)
- Received previous chemotherapy
- Symptoms of nausea or vomiting at baseline (disease related)
- On chronic anti-emetic therapy
- On daily corticosteroids prior to initiation of chemotherapy
- Allergic to steroids, 5HT3 or NK-1
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 |
|---|---|---|
| Dexamethasone, Ondansetron, AprepitantAlso: Decadron, Zofran, EmendArm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary. | Drug | Arm B: Dexamethasone, Ondansetron, Aprepitant |
| Arm A: Standard Anti-emetic regimenTreating physician's discretion for type of anti-emetic to be prescribed. | Other | Arm A: Standard Anti-emetic regimen |
Primary outcome
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
Time frame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines.
1 secondary outcome
Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
Time frame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 26562292Clemons M, Bouganim N, Smith S, Mazzarello S, Vandermeer L, Segal R, Dent S, Gertler S, Song X, Wheatley-Price P, Dranitsaris G. Risk Model-Guided Antiemetic Prophylaxis vs Physician's Choice in Patients Receiving Chemotherapy for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):225-31. doi: 10.1001/jamaoncol.2015.3730.
Related trials for Emesis
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.
Mark Clemons, Dr. principal investigator
The Ottawa Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Ondansetron, Aprepitant and Arm A: Standard Anti-emetic regimen in people with Emesis, run by Ottawa Hospital Research Institute 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms (time frame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01913990, which also lists 1 linked publication.
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 30 Jan 2017.