Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: SPA score: SPA risk score-based chemotherapy dose adjustment along with Olanzapine
Patients will be assigned a risk score based on the following parameters:
Subjective Global Assessmen
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed cancer (lung, gastroesophageal, pancreaticobiliary (PB)) cancers 2. Locally advanced inoperable and metastatic cancer patients not suitable for curative therapy and planned for first-line palliative chemotherapy 3. Patients who have previously received adjuvant/neoadjuvant chemotherapy can be included in the study if they have received chemotherapy more than 6 months before randomization 4. No major surgery within the last 4 weeks, excepting palliative surgeries like colostomy, GJ, biliary drainage, etc. 5. Haematological, hepatic, and renal function parameters satisfying the parameters mentioned below - a. Haematological- Hb more than 80 g/L, ANC more than or equal to 1.5 x 10 raised to 9/L, platelets more than or equal to 100 x 10 raised to 9/L. b. Liver function- bilirubin less than or equal to 2 x upper limit normal (ULN), AST/ALT less than or equal to 5 times ULN c. Renal function- Creatinine clearance more than or equal to 40 mL/min d. Baseline ECG/2D Echocardiography LVEF more than or equal to 50%
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to chemotherapy drugs used in the study 2. Do not give consent for the study 3. Pregnancy or lactation 4. Patient planned for targeted therapy alone 5. Symptomatic, untreated brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade more than or equal to 2 non-haematological and Grade more than or equal to 3 haematological chemotherapy-related toxicity by NCI CTCAE v5.0Timepoint: Assessed before each cycle and at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life by Cancer Institute-Quality of Life QuestionnaireTimepoint: Assessed before each cycle and at 12 weeks;Cumulative frequency of haematological Grade more than or equal to 3 and non-haematological Grade more than or equal to 2 chemotherapy-related toxicityTimepoint: Assessed before each cycle and at 12 weeks;Disease response rates by RECIST 1.1 criteriaTimepoint: 12 weeks;Dose intensity, delays and modificationsTimepoint: Assessed before each cycle and at 12 weeks;Chemotherapy discontinuation ratesTimepoint: 12 weeks;Progression-free survivalTimepoint: 1 year;Overall survivalTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactRajat Soge
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed