RCT of Olanzapine for Control of CIV in Children Receiving HSCT Conditioning

Official Title

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant Conditioning

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 hematopoietic stem cell transplant (HSCT) conditioning experience CINV 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 chemotherapy for HSCT conditioning.

Trial Description

Primary Outcome:

• Rate of CIV control during the acute phase

• complete CINV control
• Safety profile of olanzapine based on toxicities
• Safety profile of olanzapine based on weight
• Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
• Safety profile of olanzapine based on prolactin
• Safety profile of olanzapine based on amylase
• Safety profile of olanzapine based on creatine phophotase
• Safety profile of olanzapine based on triglycerides
• Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
• Impact of olanzapine on HSCT outcomes on incidence of GVHD
• Impact of olanzapine on HSCT outcomes on severity of GVHD
• Association between PeNAT and MASCC Antiemesis Tool (MAT) scores

View this trial on ClinicalTrials.gov