Health Condition 1: null- Advanced Ca Cevix
Conditions
Interventions
Intervention1: Curcumin: 4gms
Control Intervention1: Placebo: 4gms
Sponsors
Department of Biotechnology
Department of Biotechnology, Block-2, CGO Complex , Lodhi Road, New Delhi 110003
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with histologically proven invasive squamous cell carcinoma of the cervix in stages IIB, IIIA and IIIB 2. Age >18 and 3. No history of prior malignancy except basal cell carcinoma of the skin 4. ECOG performance status 5. Normal haematological and biochemical parameters, including normal renal function (WBC count >3500/cmm, platelet count >100 000/cmm, Hb >9 g/dl, serum creatinine 6. No associated co-morbid conditions that preclude participation in the study such as HIV/AIDS 7. Women who give informed consent for the study 8. Those who agree to come regularly for follow up 9. Women who are not pregnant or lactating
Exclusion criteria
Exclusion criteria: 1. Patients who have been operated upon for cervical cancer or have undergone any pelvic surgery before registering in the study 2. Patients who have a histological type of cancer other than squamous cell carcinoma 3. Those with a known allergy/intolerance to curcumin 4. Patients unable or unlikely to come for regular follow up 5. Those unlikely to follow study instructions 6. Pregnant women and nursing mothers 7. Patients who have received chemotherapy or radiotherapy within 3 weeks of the screening visit 8. Participation in any experimental treatment protocol or therapy within 28 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of curcumin (at a daily dose of 4 g/day for 42?49 days), along with standard radiotherapy and chemotherapy, in improving the 5-year disease-free survival rate (from 40% to 50%) in patients with advanced cervical cancer (Stages IIB, IIIA and IIIB).Timepoint: 5yrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.In Vivo study :To determine whether treatment with study drug affects the expression of HPV, and PCNA and p16 INK 4a levels in exfoliated cervical cells of patients with advanced cervical cancer. 2.In vitro study To study the effect of curcumin as a chemoadjuvant for cisplatin in cervical cancer cell lines on proliferation and apoptosis-related genes. The effects of curcumin on molecular targets in HPV-positive and -negative cervical cancer cell lines will also be studied to determine whether curcumin can sensitize these cervical cancer cells to chemotherapy in vitro. Timepoint: 5yrs | — |
Countries
India
Contacts
Public ContactDr Sunesh Kumar Jain
Faculty member, Department of Obs&Gynae, AIIMS
Outcome results
None listed