|
Title
|
Phase IIb/III study to determine efficacy of Curcumin and Metformin to reduce the incidence of second primary tumours of aero-digestive tract in patients with history of head and neck squamous cell carcinoma.. Study design / Type : A phase IIb/III, placebo-controlled, double-blind randomized clinical trial. |
|
Investigators
|
Dr Moni Abraham Kuriakose |
|
Participating Centres
|
|
|
Number of participants
|
1500 |
|
Status
|
Ongoing |
|
Synopsis
|
This trial is intended to determine the efficacy of Curcumin and metformin to reduce the incidence of second primary tumours of aero-digestive tract in patients with history of head and neck squamous cell carcinoma, who have completed curative intent treatment. The trial design is Phase IIb/III, with a target total sample size of 1500 subjects. Phase IIb sample size would be 200; these 200 subjects and the remaining 1300 subjects would then proceed into the Phase III part of the trial.
The total number of participating centers would be 11, out of which approximately 4-5 centers would be part of Phase IIb. The study also aims to understand the therapeutic benefit of Curcumin and Metformin in lowering recurrence of primary tumor; efficacy of Curcumin and Metformin towards regression of existing oral premalignant lesions or reduction in occurrence of new oral premalignant lesions; long term safety and effectiveness of Curcumin and Metformin, as well as the clonality and molecular basis of second primary tumor development. |
SPT-Curcumin in head and neck ca
Color Switch
Copyright © 2016 Tata Memorial Centre. All rights reserved.