Efficacy of olanzapine in comparison with placebo in treatment of anorexia in children aged 7 to 15 years with precursor lymphoid neoplasm during induction chemotherapy: A double blinded randomised controlled pilot study

This study will be conducted in department of pediatrics, JIPMER, Puducherry. Permission will be obtained from JIPMER Postgraduate research monitoring committee (PGRMC) and the institute of ethics committee (IEC) and CTRI registration prior to enrollment of first patient to conduct the study. This study shall include children of age 7 to 15 years with precursor lymphoid neoplasm on induction chemotherapy. All consecutive children with precursor lymphoid neoplasm receiving induction chemotherapy will be included during study period of January 2025 to December 2026. Written informed consent will be taken from the parents/LAR of the study participants and verbal assent from participants aged 7 to 12 years and written assent from children older than 12 years. Stratified block randomisation with block size of 6 will be done. Stratification will be based on whether patient is treated as standard or non standard risk of treatment protocol. Control and intervention group will be labelled as either group 1 or group 2. Control group will receive chemotherapy drug and placebo. Intervention group will receive chemotherapy drug and olanzapine. Randomisation will be done by computer generated random sequence and allocation concealment will be done by SNOSE technique. Once patient gets enrolled, evaluation of nutritional status and anorexia will be done. Parameter for nutritional status assessment will be weight, height, tsft. Anorexia will be assessed using pediatrics FAACT score V.2. Dietary information will be obtained on day 7 and day 34 of induction chemotherapy. The dose of olanzapine or placebo will be calculated based on weight at the time of enrollment and maximum dose will be capped at 2.5 mg per day. All participants will receive chemotherapeutic drugs. They will receive placebo or olanzapine based on randomisation. They will be followed up for 35 days during induction chemotherapy. They will be observed for treatment response and adverse effects like drowsiness, dystonia, urinary retention if any. Pediatrics FAACT score v.2 will be used at the end of 7 and 35 days of induction chemotherapy. Weight will be measured daily. Height and TSFT will bed done at day 35 of induction chemotherapy. Modified intention to treat as well as per protocol analysis will be performed.