Define role of chronomodulation in Gemcitabinne chemotherapy

Phase 2

• Conditions: Health Condition 1: C23- Malignant neoplasm of gallbladder

• Registration Number: CTRI/2023/05/053195
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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<=30ml/min, ALT/AST within <5 Upper normal limit , Serum total Bilirubin < 3 mg/dL)

Patient willing to participate in the study

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified