Health Condition 1: C400- Malignant neoplasm of scapula andlong bones of upper limb Health Condition 2: C401- Malignant neoplasm of short bonesof upper limb Health Condition 3: C402- Malignant neoplasm of long bones of lower limb Health Condition 4: C403- Malignant neoplasm of short bonesof lower limb Health Condition 5: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb Health Condition 6: C419- Malignant neoplasm of bone and articular cartilage, unspecified He
Conditions
Interventions
Intervention1: Olanzapine: Olanzapine tablets daily for 12 weeks along with standard dietary counselling.
Dose of 1.25 mg for body weight 10 to 20 kg and 2.5 mg tablet for more than or equal to 20 kg
Sponsors
Prof Sameer Bakhshi PI
Eligibility
Inclusion criteria
Inclusion criteria: a) Children and adolescents aged 2 to b) Body weight of atleast 10 kilograms c) Diagnosis of a solid malignancy d) Chemotherapy/ Radiotherapy na ve e) Planned to be initiated on first cycle of chemotherapy
Exclusion criteria
Exclusion criteria: 1 Overweight and obese children or adolescents (For children aged 2 years and above to less than 5 years: obesity shall be defined as per World Health Organization (WHO) as a weight-for-height (WFH) Z-score greater than three; For children and adolescents aged 5 years and above up to 18 years, obesity shall be defined as per Indian Academy of Pediatrics (IAP) as a body-mass index (BMI) Z-score greater than 1.33 in boys and 1.63 in girls) 2 Children who are not planned to be initiated on chemotherapy 3 Intake of olanzapine for more than 5 days per month for non trial indication 4 Children taking antipsychotics or antidepressants for any psychiatric or non psychiatric indication 5 Prolonged use of systemic corticosteroids Prednisolone or prednisolone-equivalent of more than or equal to 5 mg for more than a week in the previous 28 days. 6 Children with intracranial neoplasms 7 Children with hematological malignancies 8 Children with intellectual disability 9 Children with concomitant chronic infections like osteomyelitis, tuberculosis, meningitis, suppurative infections, etc. 10 Inability to take oral medications 11 Severe organ damage based on laboratory investigations within 2 weeks at the time of screening (hepatic- transaminitis more than or equal to 5 times upper limit normal or bilirubin more than or equal to three times upper limit of normal; renal- serum creatinine levels more than or equal to 1.5 times upper limit of normal; any evidence of heart failure) 12 Qtc interval prolongation: more than or equal to 450 msec by Fredericia formula 13 Raised serum amylase levels (more than upper limit normal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children achieving weight gain more than or equal to 5 percentage at the end of 12 weeks of receipt of olanzapine plus standard dietary counselling versus standard dietary counselling alone among those undergoing chemotherapy for solid malignanciesTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in anorexia scoresTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Change in quality of lifeTimepoint: 6 weeks and 12 weeks;Change in anthropometric parametersTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Event free survival and Overall survivalTimepoint: 12 weeks;Improvement in caloric intakeTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Adverse effect profileTimepoint: 3 weeks 6 weeks 12 weeks;Grade 3 or 4 chemotoxicity assessmentTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactSameer Bakhshi
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed