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NCT Number: NCT02861859

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Ottawa Hospital Research Institute Cance Center

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olanzapine

Drug

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

Other names: Mylan-Olanzapine

Olanzapine Placebo

Drug

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

Primary outcomes

  1. High personal risk of Chemotherapy-induced nausea and vomiting

    Time frame: 3 years

    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

Secondary outcomes

  1. High personal risk overall total control of Chemotherapy-induced nausea and vomiting

    Time frame: 3 years

    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.

  2. Improvement of patient Health Related Quality of Life by completing a patient diary and quality of life questionnaire in the high risk cohort

    Time frame: 3 years

    To assess whether adding olanzapine to a standard antiemetic regimen significantly improves patient Health Related Quality of Life in the high risk cohort

  3. Safety of olanzapine with respect to sedation and extrapyramidal side effects in the high risk cohort

    Time frame: 3 years

    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

Other outcomes

  1. Low personal risk of Chemotherapy-induced nausea and vomiting

    Time frame: 3 years

    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.

  2. Low personal risk overall total control of Chemotherapy-induced nausea and vomiting

    Time frame: 3 years

    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. Improvement of patient Health Related Quality of Life by completing a patient diary and a quality of life questionnaire in the low risk cohort

    Time frame: 3 years

    To assess whether adding olanzapine to a standard antiemetic regimen significantly improves patient Health Related Quality of Life in the low risk cohort.

  4. Safety of olanzapine with respect to sedation and extrapyramidal side effects in the low risk cohort

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2016
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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