Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Low Dose Olanzapine: Oral Tablet -Olanzapine 2.5 mg
OD for 12-16 weeks
Control Intervention1: Placebo: Oral Tablet- Matching Placebo (containing starch) for 12-16 weeks
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 - 65 years at the time of enrolment 2. Male and Female 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 4. LA-HNSCC – Stage III, IVA, IVB planned for radical radiation (with or without concurrent chemotherapy) 5. Patients taking oral/enteral diet at least in liquid or semisolid form 6. Patients with Adequate organ function at time of participation, defined as Hematological: Hemoglobin more than 9gm/dl, TLC more than 4000 mm3, ANC more than 1500/mm3 ,Platelet more than 100000/mm3, Liver Function test: Bilirubin less than 2 x upper limit normal (ULN), AST/ALT/ ALP less than 2.5 x ULN, PTless than 1.5 X ULN or International Normalized Ratio less than 1. 5, Renal Function test: Creatinine less than 1.5 X ULN, Creatinine, Clearance more than 60 ml/mins, Magnesium more than lower limit of normal
Exclusion criteria
Exclusion criteria: 1. Earlier chemotherapy / radiotherapy 2. Intake of olanzapine in last 2 monthsfor any other indications 3. On any antipsychotic or antidepressants 4. Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks) 5. Pregnancy 6. Any other synchronous malignancy or uncontrolled viral/bacterial infection (such as tuberculosis, hepatitis B or Hepatitis C infection) 7. Planned for adjuvant chemoradiation, Neoadjuvant chemotherapy,Psychiatric problem that required immediate attention, including acute suicidality; 8. A current diagnosis of substance abuse or dependence, schizophrenia, schizophreniform disorder, or bipolar illness 9. Neurological problem, including movement disorder (e.g., tardive dyskinesia), history of a seizure disorder, or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss more than 5% from baselineTimepoint: Within one week after treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| mean change in body weight from baseline Timepoint: within one week of treatment completion;change in symptoms of anorexia as assessed by VAS and FAACT-ACSTimepoint: within one week of treatment completion;change in quality of life (QOL) as assessed by CI-QOL-QTimepoint: within one week of treatment completion;change in nutrition & calorie intakeTimepoint: within one week of treatment completion;change in body composition parameters such as LBM, FFMI, FMI as assessed by BIATimepoint: within one week of treatment completion;toxicity profile (highest grade) during chemoradiationTimepoint: within one week of treatment completion;Time to develop more than 2 grade toxicities during chemoradiationTimepoint: within one week of treatment completion;drug side effect/ adverse event profileTimepoint: within one week of treatment completion;Treatment response as assessed by RECIST criteriaTimepoint: At 2 months of treatment completion;Event free survival & Overall survivalTimepoint: At 6 months of treatment completion | — |
Countries
India
Contacts
Public ContactPooja Sethi
JIPMER
Outcome results
None listed