To study the effect of nutritional advise and olanzapine on weight gain among children with cancer

Phase 3

Registration Number: CTRI/2024/03/064371

Lead Sponsor: Prof Sameer Bakhshi PI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1Children and adolescents aged 2 to 18 years at the time of enrolment

2Body weight of atleast 10 kilograms

3Diagnosis of a solid malignancy

4Chemotherapy or Radiotherapy naïve

5Planned to be initiated on first cycle of chemotherapy

6Belongs to normal nutritional or under-nutritional status

Exclusion Criteria

1Overweight and obese children or adolescents

2Children who are not planned to be initiated on chemotherapy

3Intake of olanzapine for more than 5 days per month for non trial indication

4Children taking antipsychotics or antidepressants for any psychiatric or non psychiatric indication

5Prolonged 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.

6Children with intracranial neoplasms

7Children with hematological malignancies

8Children with intellectual disability

9Children with concomitant chronic infections like osteomyelitis, tuberculosis, meningitis, suppurative infections, etc.

10Inability to take oral medications

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse effect profileTimepoint: 3 weeks 6 weeks 12 weeks;Change in anthropometric parametersTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Change in quality of lifeTimepoint: 6 weeks and 12 weeks;Event free survival and Overall survivalTimepoint: 12 weeks;Grade 3 or 4 chemotoxicity assessmentTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Improvement in anorexia scoresTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks;Improvement in caloric intakeTimepoint: 3 weeks 6 weeks 9 weeks and 12 weeks