Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 10
- Primary Endpoint
- Rate of CIV control during the acute phase
Overview
Brief Summary
Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Olanzapine
Standard antiemetics plus olanzapine
Intervention: Olanzapine (Drug)
Placebo Oral Tablet
Standard antiemetics plus placebo
Intervention: Placebo Oral Tablet (Drug)
Outcomes
Primary Outcomes
Rate of CIV control during the acute phase
Time Frame: up to 8 days
Partial control is defined as no more than two vomits or retches during any 24-hr period
Secondary Outcomes
- Safety profile of olanzapine based on creatine phophotase(up to 1 month)
- Safety profile of olanzapine based on amylase(up to 1 month)
- complete and partial CINV control(up to 1 month)
- Safety profile of olanzapine based on toxicities(up to 1 month)
- Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)(up to 1 month)
- Safety profile of olanzapine based on triglycerides(up to 1 month)
- Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease(From first HSCT conditioning dose until 100 days post-HSCT)
- Impact of olanzapine on HSCT outcomes on incidence of GVHD(From first HSCT conditioning dose until 100 days post-HSCT)
- Impact of olanzapine on HSCT outcomes on severity of GVHD(From first HSCT conditioning dose until 100 days post-HSCT)
- Association between PeNAT and MASCC Antiemesis Tool (MAT) scores(up to 1 month)
- Safety profile of olanzapine based on weight(up to 1 month)
- Safety profile of olanzapine based on prolactin(up to 1 month)
Investigators
Lee Dupuis
Principal Investigator
The Hospital for Sick Children