Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02861859
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Olanzapine Drug: Olanzapine Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Comparator

Eligible patients at high personal risk of CIVN will receive Standard of Care Regimen: Aprepitant (125 mg PO OD day 1, 80mg OD days 2-3), ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine placebo (PO OD days 1-4).

Eligible patients at low personal risk of CIVN will receive Standard of Care Regimen: Ondansetron (8mg PO, BID on Day 1 of each cycle,), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine placebo (PO OD days 1-4).

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

Active Comparator: Olanzapine

Eligible patients at high personal risk of CIVN will receive Standard of Care Regimen: Aprepitant (125 mg PO, OD day 1, 80mg OD days 2-3), ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine (5 mg PO OD days 1-4).

Eligible patients at low personal risk of CIVN will receive Standard of Care Regimen: Ondansetron (8mg PO, BID on Day 1 of each cycle), dexamethasone (12 mg IV x1 before chemotherapy and 4mg PO BID days 2-3) and olanzapine (5 mg PO OD days 1-4).

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861859


Contacts
Layout table for location contacts
Contact: Mark Clemons, MD 613-737-7700 ext 70170 mclemons@toh.on.ca

Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Research Institute Cance Center Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Mark J Clemons, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Mark Clemons, MD The Ottawa Hospital

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02861859     History of Changes
Other Study ID Numbers: OTT 16-05
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Hospital Research Institute:
Breast cancer
Breast Carcinoma
Breast Tumors
Chemotherapy
Antiemetic effects
Antiemetic drugs
Drug Therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Vomiting
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents