| CTRI Number |
CTRI/2008/091/000195 [Registered on: 03/10/2008] |
| Last Modified On: |
19/09/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Phase II/III Randomized Placebo Controlled Clinical Trial of Curcumin in Resectable Stage III and IV Squamous Head and Neck Cancers (Oral cancers) |
|
Scientific Title of Study
|
Phase II/III Randomized Placebo Controlled Clinical Trial of Curcumin in Resectable Stage III and IV Squamous Head and Neck Cancers (Oral cancers) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCS-DBT-P102 |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Alok Thakar |
| Designation |
|
| Affiliation |
|
| Address |
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593492 |
| Fax |
011-26588663 |
| Email |
drathakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Alok Thakar |
| Designation |
|
| Affiliation |
Principal Investigator |
| Address |
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593492 |
| Fax |
011-26588663 |
| Email |
drathakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Alok Thakar |
| Designation |
|
| Affiliation |
|
| Address |
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593492 |
| Fax |
011-26588663 |
| Email |
drathakar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Biotechnology, Ministry of Science & Technology, Government of India |
|
|
Primary Sponsor
|
| Name |
DBT |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Alok Thakar |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences,Ansari Nagar-110029
New Delhi
DELHI |
011-26593492
011-26588663
drathakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head & Neck Cancers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcumin Capsule |
3.6 gms/day for 6 months |
| Comparator Agent |
Placebo Capsule |
3.6 gms/day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Histologically confirmed squamous cancers of oral cavity
2. Stage III-IV (resectable lesions)
3. Karnofsky?s scale > 60%
4. Patients selected to undergo curative treatment (otherwise generally fit patients)
5. Patient has signed and dated the Informed Consent Document
6. Patient is willing and able to fully participate for the duration of the study
|
|
| ExclusionCriteria |
| Details |
1. All patients with unresectable lesions
2. Poor Karnofsky?s scale
3. Patients with non-squamous cancers.
4. Patients who does not comply with assigned
complete treatment protocol.
5. Patients with potential behavior and cognitive
impairment. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of curcumin in subjects with histologically proven resectable stage III and IV squamous cancers of the head and neck (to monitor the rate of failure / recurrences) following standard treatment
|
Baseline, 24 hrs, 7 days & 6 months for estimation of curcumin.
For rate of failure/recurrence: every 2 months for 6 months and thereafter every 2 months till recurrence or upto 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate curcumin induced modulation of biomarkers
-COX-2/PGE2
-IL-6
|
Baseline, 24 hrs, 7 days & 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
19/04/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is intended to determine the efficacy of curcumin in subjects with histologically proven resectable stage III and IV squamous cancers of the head and neck (to monitor the rate of failure / recurrences) following standard treatment. It also aims to evaluate curcumin induced modulation of biomarkers (COX-2, PGE2 & IL-6). |