AzTrials
AzTrials

Chemotherapy-induced Nausea and VomitingPhase 3FORESIGHTNCT04075955

Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy

A Phase 3 study testing Zyprexa® (OLANZapine 5MG) and Emend® (Aprepitant) in people with Chemotherapy-induced Nausea and Vomiting, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Olanzapine is frequently used off-label as an adjunct antiemetic in clinical oncology settings. North American oncology guidelines recommend it as salvage therapy and as add-on to the standard triple regimen; some suggest it may also be effective as an initial triple therapy (olanzapine replacing the NK-1 antagonist)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
Zyprexa® (OLANZapine 5MG) and Emend® (Aprepitant)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
29 Apr 2019to 31 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients receiving a first cycle of highly emetogenic chemotherapy (or having received one more than 2 years prior to randomisation) at the oncology outpatient clinic at Charles LeMoyne or Haut-Richelieu hospital between April 29th and September 20th 2019.
  • 18 years old and over
  • Patient receiving highly emetogenic chemotherapy
  • ECOG from 0 to 2 inclusively
  • Creatinine clearance ≥ 30ml/min; total bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 3.0 x ULN
  • Patient without electrolytic imbalance or corrected imbalance
  • Signed written and informed consent

Who cannot join

  • Patient doesn't speak french or english
  • Patient to receive treatment whose protocol includes a second dose of highly emetogenic chemotherapy before day 6 of the cycle
  • Patient to receive chemotherapy treatment that already contains corticosteroids (dexamethasone or prednisone) given as antineoplastic
  • Nausea or vomiting present ≤ 24h before randomisation
  • Untreated brain metastases
  • Severe cognitive disorder or dementia or inability to properly understand or document the presence of nausea or vomiting or the use of salvage therapy
Show all 19Show fewer
  • History of uncontrolled cardiac arrhythmia, unstable angina or known QT prolongation (> 500ms)
  • Uncontrolled diabetes
  • Patient to receive abdominal radiotherapy during the first cycle of chemotherapy
  • Bowel obstruction, intestinal ileus or ascites present at cycle 1
  • Chronic alcoholism
  • Severe uncontrolled psychologic disorder
  • Patient taking antipsychotic treatment on a regular basis
  • Patient taking drugs with a contraindication when administered concurrently with one of the protocol drugs
  • Dysphagia (incapacity to swallow the pills included in the study)
  • Hypersensitivity, severe reaction or allergy to one of the study treatments
  • Participation in another research protocol
  • Pregnancy or breastfeeding
  • Subject that does not have a valid phone ou email address

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hôpital Charles-LeMoyne

    Greenfield Park, Quebec, J4V2H1

Other trials in Canada

About this study

Official title: FORESIGHT: Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy: a Randomised Controlled Trial Against Aprepitant in Triple Therapy

Olanzapine is frequently used off-label as an adjunct antiemetic in clinical oncology settings. North American oncology guidelines recommend it as salvage therapy and as add-on to the standard triple regimen; some suggest it may also be effective as an initial triple therapy (olanzapine replacing the NK-1 antagonist) based on phase II and III trials.

This prospective, multi-center, open-label study aims to evaluate the feasibility of a large scale randomised controlled trial to compare the effectiveness and tolerability of 5mg orally once daily olanzapine in triple antiemetic therapy versus the standard treatment of aprepitant + ondansetron + dexamethasone in treatment-naive patients receiving the first cycle of a highly emetogenic chemotherapy. Secondary outcomes include effectiveness, tolerability and quality of life assessments. Effectiveness will be measured with complete response and complete remission rates in each treatment arms. Tolerability and patient quality of life will be evaluated with a standardised side effect form and validated questionnaires; ESAS-R and FLIE.

The role of olanzapine-based triple therapy in prevention of chemotherapy-induced nausea and vomiting remains founded on low-quality evidence. To the investigator's knowledge, this study will be the first large scale direct comparison of 5mg olanzapine versus aprepitant in triple therapy.

Being tested
Zyprexa® (OLANZapine 5MG), Emend® (Aprepitant)
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zyprexa® (OLANZapine 5MG)Drug

    Also called Zyprexa®

    Olanzapine 5mg orally at bedtime for 4 days (starting the day before the chemotherapy)

    Ondansetron 16mg orally pre-chemotherapy on day 1

    Dexamethasone 12mg orally pre-chemotherapy on day 1

    Dexamethasone 8mg orally twice a day for 6 doses (starting on the morning of day 2)

  • Emend® (Aprepitant)Drug

    Also called Emend®

    Aprepitant 125mg orally pre-chemotherapy on day 1, then 80mg orally once daily on days 2 and 3

    Ondansetron 16mg orally pre-chemotherapy on day 1

    Dexamethasone 12mg orally pre-chemotherapy on day 1

    Dexamethasone 8mg orally once daily for 3 doses (starting on the morning of day 2)

Study groups in NCT04075955
Study groupRoleWhat they receive
Study treatment groupExperimentalOlanzapine in combination with ondansetron and dexamethasone
Receives: Drug: Zyprexa® (OLANZapine 5MG)
Standard treatment groupActive comparatorAprepitant in combination with ondansetron and dexamethasone
Receives: Drug: Emend® (Aprepitant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients recruited

    At least 60 patients over 5 months meet the eligibility criteria and agree to participate.

    Measured: 5 months

  2. Eligible patients' interest to participate

    At least 35% of all eligible patients agree to participate

    Measured: 5 months

  3. Completion of the diary

    At least 75% of recruited patients complete 100% of their patient diary.

    Measured: 5 months

  4. Cost

    The total cost of the study does not exceed 10,000$

    Measured: 5 months

  5. Number of centres

    The study can be done at two sites.

    Measured: 5 months

Secondary outcomes (4)

  1. Compare effectiveness of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of proportion of participant with complete response in the overall phase.

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no nausea, no vomiting and no rescue therapy. Intensity of nausea episodes will be measured with a 0 to 10 visual scale. Intensity of vomiting episodes will be measured with a 0 to 10 visual scale.

    Measured: 0 to 120 hours

  2. Compare effectiveness of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of proportion of participant with complete remission in the overall phase.

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    Complete remission was defined as no vomiting and no rescue therapy. Intensity of vomiting episodes will be measured with a 0 to 10 visual scale.

    Measured: 0 to 120 hours

  3. Compare tolerability of olanzapine 5mg versus standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy in regard of prevalence of adverse events due to the antiemetic therapy in each arm.

    Proportion of patients who experienced adverse events associated with each of the treatment arms. Adverse events obtained according to the ESAS-R questionnaire and a follow-up interview at the second cycle of chemotherapy.

    Definition and gradation of adverse events would be following the Common Terminology Criteria for Adverse Events (CTCAE) 5th edition.

    Measured: During the complete duration of the first cycle of chemotherapy (1 cycle is 14 to 28 days)

  4. Compare patient's assessment of quality of life between those receiving olanzapine 5mg and those receiving standard aprepitant in a triple antiemetic therapy in patients receiving a first cycle of highly emetogenic chemotherapy.

    Quality of life score obtained according to the FLIE questionnaire

    Measured: 0 to 120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2019
  2. Study start29 Apr 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075955
Sponsor's protocol ID
2019-389
Acronym
FORESIGHT
Status last verified
Aug 2020
First submitted
10 May 2019
Last updated
19 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zyprexa® (OLANZapine 5MG) and Emend® (Aprepitant) in people with Chemotherapy-induced Nausea and Vomiting, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients recruited (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
FORESIGHT Clinical Trial NCT04075955 | AzTrials