Clinical trial NCT02861859: Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study
Official title: A Randomized Trial of Individualised Care Versus Standard Care for Breast Cancer Patients at High Risk for Chemotherapy Induced Nausea and Vomiting. The ILIAD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
Breast Carcinoma
Breast Tumors
Chemotherapy
Antiemetic effects
Antiemetic drugs
Drug Therapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer patients receiving emetogenic chemotherapy regimens such as anthracycline with cyclophosphamide-based chemotherapy and platinum-based chemotherapy.

To help clinicians prescribe antiemetic medications in a more patient-centered, evidence-based and cost-effective manner, we've developed the world's first validated risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of this, it is now possible to perform a trial of personalized precision antiemetic therapy for breast cancer patients.

Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains among the most feared and expected side effects of chemotherapy for breast cancer. Inadequately controlled CINV can significantly reduce a patient's quality of life, impair functional activity, lead to chemotherapy dose delays and reductions, and even discontinuation of treatment. The merit of current antiemetic medications is based on their ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is the major issue for breast cancer patients.

With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for CINV. For patients at low personal risk for CINV the investigators will also evaluate guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine (5 mg).


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed invasive breast cancer (stage I-III) scheduled to receive neo/adjuvant anthracycline/cyclophosphamide or platinum-based chemotherapy
* ≥18 years
* Able to provide consent and complete all study-related diaries and questionnaires.

Exclusion Criteria:

* Received previous chemotherapy
* Symptoms of nausea or vomiting at baseline
* On chronic antiemetic therapy (e.g. metoclopramide); on daily long term oral steroids prior to chemotherapy
* Allergic or having a medical condition that makes the administration of olanzapine, aprepitant, 5-HT3 antagonists or dexamethasone contraindicated
* Uncontrolled diabetes
* Known/documented medical/psychiatric illness that would interfere with patients' ability to complete the diary and study-related questionnaires.

Primary outcomes:
measure: High personal risk of Chemotherapy-induced nausea and vomiting
timeFrame: 3 years
Secondary outcomes:
measure: High personal risk overall total control of Chemotherapy-induced nausea and vomiting
timeFrame: 3 years
measure: Improvement of patient Health Related Quality of Life by completing a patient diary and quality of life questionnaire in the high risk cohort
timeFrame: 3 years
measure: Safety of olanzapine with respect to sedation and extrapyramidal side effects in the high risk cohort
timeFrame: 3 years
Other outcomes:
measure: Low personal risk of Chemotherapy-induced nausea and vomiting
timeFrame: 3 years
measure: Low personal risk overall total control of Chemotherapy-induced nausea and vomiting
timeFrame: 3 years
measure: Improvement of patient Health Related Quality of Life by completing a patient diary and a quality of life questionnaire in the low risk cohort
timeFrame: 3 years
measure: Safety of olanzapine with respect to sedation and extrapyramidal side effects in the low risk cohort
timeFrame: 3 years
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute Cance Center
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
References: