Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861859
• Other study ID #: OTT 16-05
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: December 23, 2019

Study information

• Verified date: February 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Vomiting

Intervention

Drug:
• Olanzapine
Olanzapine 5 mg (2 x 2.5 mg) PO OD (once a day) on days 1-4.
• Olanzapine Placebo
Olanzapine Placebo 5 mg (2 x 2.5 mg) PO OD (once a day) on days 1-4.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Research Institute Cance Center	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Low personal risk of Chemotherapy-induced nausea and vomiting	To assess whether the addition of olanzapine to the standard antiemetic regimens significantly reduces the incidence of nausea in patients at personal low-risk for Chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy.	3 years
Other	Low personal risk overall total control of Chemotherapy-induced nausea and vomiting	To compare overall total control of CINV (i.e. no nausea, no vomiting and no use of rescue medications) between the two study arms in the low risk cohort.	3 years
Other	Improvement of patient Health Related Quality of Life by completing a patient diary and a quality of life questionnaire in the low risk cohort	To assess whether adding olanzapine to a standard antiemetic regimen significantly improves patient Health Related Quality of Life in the low risk cohort.	3 years
Other	Safety of olanzapine with respect to sedation and extrapyramidal side effects in the low risk cohort	To assess the safety of adding olanzapine as a standard antiemetic regimen particularly with respect to sedation and extrapyramidal side effects in the low risk cohort.	3 years
Primary	High personal risk of Chemotherapy-induced nausea and vomiting	To assess whether the addition of olanzapine to the standard antiemetic regimens significantly reduces the incidence of nausea during the overall period, over repeated cycles of chemotherapy in patients at high personal risk for Chemotherapy-induced nausea and vomiting	3 years
Secondary	High personal risk overall total control of Chemotherapy-induced nausea and vomiting	To compare overall total control of Chemotherapy-induced nausea and vomiting (i.e. no nausea, no vomiting and no use of rescue medications) between the two study arms in the high risk cohort.	3 years
Secondary	Improvement of patient Health Related Quality of Life by completing a patient diary and quality of life questionnaire in the high risk cohort	To assess whether adding olanzapine to a standard antiemetic regimen significantly improves patient Health Related Quality of Life in the high risk cohort	3 years
Secondary	Safety of olanzapine with respect to sedation and extrapyramidal side effects in the high risk cohort	To assess the safety of adding olanzapine as a standard antiemetic regimen particularly with respect to sedation and extrapyramidal side effects in the high risk cohort	3 years