Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: melatonin: In 2 groups of study 2, 20 mg Melatonin will be administered to patients receiving chemotherapy for 14 days starting from chemotherapy cycle 1 day 8.
Control Intervention1: n
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH
Eligibility
Inclusion criteria
Inclusion criteria: Patients on first line palliative chemotherapy in metastatic cancer Age >=18 years Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2 Adequate organ function (Absolute neutrophil count>=1500/mm3, Platelet count>= 100,000/mm3, Hb>=9 gm/dL, Serum Creatinine Patient willing to participate in the study
Exclusion criteria
Exclusion criteria: 1.Expected survival less than 6 months 2.Documented case of cerebral ischemia, transient ischemic attack, stroke, CNS metastasis or any other central nervous system disorders 3. Patient on beta-blockers (propranolol or atenolol), fluvoxamine, desipramine, Tricyclic anti-depressant, MAO inhibitors, Antiepileptics (Sodium Valproate, Carbamazepine) 4. Patients with history of any invasive neurosurgical or non-invasive neuropsychiatric procedure 5. Patients with a history of allergy to gemcitabine, melatonin, or other melatonin agonists 6. Pregnant and nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate effect of chrono-modulation on cytidine deaminase enzyme (CDA) activity in metastatic cancer patients on Gemcitabine chemotherapy To determine the effect of chrono-modulation on elimination kinetics of chrono-modulated Gemcitabine chemotherapy in metastatic cancer patients To determine the role of melatonin on elimination kinetics of chrono- modulated Gemcitabine chemotherapy in metastatic cancer patientsTimepoint: BASELINE CDA, CT1D1, CT2D8, CT2D1, CT2D8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate effect of chrono-modulation on cytidine deaminase enzyme (CDA) activity in metastatic cancer patients on Gemcitabine chemotherapy 2.To determine the role of melatonin on cytidine deaminase enzyme (CDA) activity in metastatic cancer patients on Gemcitabine chemotherapy 3.To monitor and assess the adverse effects of Gemcitabine-based chemotherapy in metastatic cancer patients using Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Timepoint: BASELINE CDA, CT1D1, CT2D8, CT2D1, CT2D8 | — |
Countries
India
Contacts
Public ContactDr Khushboo Bisht
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed