Clinical trial NCT01913990: Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emesis
Keywords: Nausea
Vomiting
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 323
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
timeFrame: 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:
measure: Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
timeFrame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Other outcomes:
measure: Difference in breakthrough anti-emetic use in the emesis risk model group compared to the standard arm; i.e.: requirements for additional oral and parenteral anti-emetics during a single chemotherapy cycle
timeFrame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Mark Clemons, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.