Does Olanzapine improve quality of life in incurable cancer patients?
- Conditions
- Health Condition 1: C80- Malignant neoplasm without specification of siteHealth Condition 2: C15-C26- Malignant neoplasms of digestive organsHealth Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs
- Registration Number
- CTRI/2022/03/041155
- Lead Sponsor
- ational cancer Institute AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method �To compare change in body weight and symptoms of anorexia (using FAACT A/CS questionnaire) in two armsTimepoint: 0 and 8 weeks;�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