Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C269- Malignant neoplasm of ill-definedsites within the digestive system Health Condition 3: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Resveratrol-copper: Resveratrol is a polyphenolic stilbenoid present in red grapes, berries, peanuts, and roots of Japanese knotweed. Resveratrol has been shown to have multiple health
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of any solid tumour malignant disease. 2.Patients scheduled to receive 5-FU based chemotherapy regimen. 3.Age >= 18 years. 4.ECOG performance status should be 0-2. 5.Subjects must have normal organ and marrow function as defined below: a.Hematologic: Absolute neutrophil count (ANC) >= 1.5 Ã? 109/L, platelet count >= 100 Ã? 109/L, and hemoglobin >= 8 g/dL (may have been transfused). b.Hepatic: Total bilirubin level c.Renal: Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula. 6.Negative pregnancy test (serum or urine) done 7.Women of reproductive potential who agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. 8.Patient willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments. 9.Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Patients with severe cognitive compromise. 2.Patients with a history of CNS disease (e.g., brain metastases, seizure disorder) 3.Known hypersensitivity to Resveratrol or copper. 4.Medical conditions such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or cardiac disease, which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. 5.Patients unwilling to participate in the study. 6.Any previous consumption of R-Cu. 7.Any active mucocutaneous toxicity from previous therapy of disease which may interfere with the evaluation of chemotoxicity. 8.Patients who have received any radiation/radiotherapy within the last one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare grade 3-5 chemotherapy-induced muco-cutaneous toxicities between the two study arms in the overall periods in patients receiving 5-FU based chemotherapy regimen;the proportion of subjects with grade 3-5 muco-cutaneous toxicity free survival on 5-FU based chemotherapy regimen.Timepoint: Approximate time for follow up:9 months post accrual of last patients. Total study duration:36 months. Final study report: approximately months post beginning study 36 months Number of centers: Single-center Final study report: approximately 36months post beginning study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare median Event - free survival between the two study arms in patients receiving 5-FU based chemotherapy regimens. 2.To compare clinical benefit rate (Complete Response, Partial response, or stable disease) between the two study arms in patients receiving 5-FU based chemotherapy regimens. 3.To compare median Overall survival between the two study arms in patients receiving 5-FU based chemotherapy regimens. 4.To compare any grade 3-5 chemotherapy-induced toxicities between the two study arms in the overall periods in patients receiving 5-FU based chemotherapy regimens. 5.To compare median time to toxicities between the two study arms in patients receiving 5-FU based chemotherapy regimens.Timepoint: Approximate time for follow up:9 months post accrual of last patients. Total study duration:36 months. Final study report: approximately months post beginning study 36 months Number of centers: Single-center Final study report: approximately 36months post beginning study | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed