Health Condition 1: null- Patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers at Tata Memorial Hospital
Conditions
Interventions
Intervention1: Trans-Resveratrol (Trade name-TransMaxTR) and Copper (Trade name-Chelated Copper): Trans-Resveratrol is available as a health supplement in capsule form (500mg) and is approved for huma
Sponsors
TMC Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients 18 years and above. 2.Patients who have given written informed consent 3.Patients with performance status of 0, 1 or 2 (ECOG scale) 4.Treatment naïve inoperable stage 4 adenocarcinoma of the distal stomach in whom the GE junction of the stomach is free of disease. 5.Histologically proven gastric adenocarcinoma; 6.No prior chemotherapy 7. No prior radiotherapy and or surgery 8. Adequate hepatic, renal, and hematologic function at baseline.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled medical comorbidities like hypertensive, diabetes mellitus, HbsAg and HIV positive, etc. 2.Presence of gastric outlet obstruction 3.Gastro-esophageal junction cancers 4.Significant neuropathy 5.Presence of brain or leptomeningeal metastases 6.Patients taking alternative / complementary treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine an effective dose-level of R-Cu that can reduce: 1) CT - induced toxicity; 2) degree of DNA damage and inflammation in PBMCs; 3) levels of circulating inflammatory cytokines (PGE2,TNF-alpha, INF-gamma IL-6, IL-1, CRP,IL-4,IL-10 and IL-11) and 4) levels of circulating chromatin in patients receiving chemotherapy for stage IV gastric cancer.Timepoint: 1) serum concentration of inflammatory cytokines on days 0, 5, 10, 15 and 20 2) levels of circulating chromatin on days 0, 5, 10, 15 and 20 3) degree of DNA damage and inflammation in PBMCs on days 0, 5, 10, 15 and 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the steady-state PK parameters for resveratrol and copper on Day 7 in patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers at 4-dose levels of R-Cu.Timepoint: The steady-state PK parameters for resveratrol and copper will be performed on Day 7 The sampling time points will be as follows: Group 1 (subjects 1 and 4 of the 4-doses of R-Cu): 0hr, 0.5hr, 3hr, 7hr, 12hr Group 2 (subjects 2 and 5 of the 4-doses of R-Cu): 0hr,1hr, 4hr, 8hr and 12hr. Group 3 (subjects 3 of the 4-doses of R-Cu): 0hr,2hr, 5hr, 10hr and 12hr. | — |
Countries
India
Contacts
Public ContactProfessor DrIndraneel Mittra
Tata Memorial Centre , Advanced Centre for Treatment , Research and Education in Cancer (ACTREC)
Outcome results
None listed