Status:
COMPLETED
Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy
Lead Sponsor:
CR-CSSS Champlain-Charles-Le Moyne
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04075955
Start Date
April 29 2019
End Date
December 31 2019
Last Update
August 19 2020
Active Locations (1)
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1
Hôpital Charles-LeMoyne
Greenfield Park, Quebec, Canada, J4V2H1