Health Condition 1: C80- Malignant neoplasm without specification of site Health Condition 2: C15-C26- Malignant neoplasms of digestive organs Health Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs
Conditions
Interventions
Intervention1: Tab.Olanzapine .: 5 mg q HS daily for 8 weeks in addition to planned treatment (chemotherapy, supportive care and nutritional advice in detail which includes type and quantity of diet
Sponsors
National cancer Institute AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Cytologically/pathologically confirmed solid cancers ( lung and Gastrointestinal cancers) with recurrent/unresectable/metastatic disease. ECOG Performance status zero to three. With adequate organ and bone marrow function. On palliative chemotherapy Palliative radiotherapy allowed Ability to understand and sign informed consent
Exclusion criteria
Exclusion criteria: Lactating and pregnant woman Not able to take pills orally and dependent on tube feeding (oral mucositis/candidiasis or dysphagia as determined by clinical examination). Gastric outlet obstruction or Intestinal obstruction. known history of central nervous system disease (e.g., brain metastases, seizure disorder or psychiatric illness) or treatment with another atypical antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for thirty days prior to or during protocol therapy. Uncontrolled diabetes mellitus. Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks) Ascites at time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1).To compare if Olanzapine in combination with palliative chemotherapy v/s Placebo in combination with palliative chemotherapy improves HRQoL (using EORTC QLQ-C30)Timepoint: 0 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To compare change in body weight and symptoms of anorexia (using FAACT A/CS questionnaire) in two armsTimepoint: 0 and 8 weeks;ââ?¬Â¢ To evaluate levels of Ghrelin, Leptin, Insulin like Growth factor-1(IGF-1) and IL-6 and other yet unspecified molecular markers (subject to availability) in preserved blood samples and correlate with clinical response and compare the same between two armsTimepoint: 0 and 8 weeks;To compare adverse events in two arms (Using CTACE v4.03)Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactBABITA KATARIA
NCI-AIIMS,Badsa,Haryana
Outcome results
None listed