| CTRI Number |
CTRI/2008/091/000194 [Registered on: 03/10/2008] |
| Last Modified On: |
19/09/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phase II Trial of Curcumin in Advanced Head and Neck Cancer Treatment |
|
Scientific Title of Study
|
Phase II Trial of Curcumin in Advanced Head and Neck Cancer Treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCS-DBT-P103 |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sunil K Saini |
| Designation |
|
| Affiliation |
|
| Address |
Himalayan Institute of Medical Sciences
Jolly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
0135-2412081 |
| Fax |
0135-2412008 |
| Email |
drsunilsaini@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sunil K Saini |
| Designation |
|
| Affiliation |
Principal Investigator |
| Address |
Himalayan Institute of Medical Sciences
Jolly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
0135-2412081 |
| Fax |
0135-2412008 |
| Email |
drsunilsaini@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sunil K Saini |
| Designation |
|
| Affiliation |
|
| Address |
Himalayan Institute of Medical Sciences
Jolly Grant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
0135-2412081 |
| Fax |
0135-2412008 |
| Email |
drsunilsaini@yahoo.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. Sunil K Saini |
Himalayan Institute of Medial Sciences |
Himalayan Institute of Medical Sciences,Jolly Grant-248140
Dehradun
UTTARANCHAL |
0135-2412081
0135-2412008
drsunilsaini@yahoo.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 |
Advanced Head & neck Cancers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
- |
- |
| Intervention |
Curcumin Capsule |
3.6 gms/day for 8-32 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patients with histo-pathological confirmed squamous cell carcinoma of head and neck (oral cavity/ pharynx/ larynx)
2. Patients who have advanced incurable cancer of head and neck region at the initial diagnosis or those who have failed all standard cancer specific treatment including chemotherapy, radiotherapy
3. Patient has signed and dated the informed consent document
4. Patient is willing and able to fully participate for the duration of the study
5. Patient with anticipated life of more than two months on clinical assessment by team members
|
|
| ExclusionCriteria |
| Details |
1. Patient is less than 18 years of age
2. Patient is participating in any other study
3. Patient with non-squamous cell cancers
4. Patient who does not comply with assigned treatment protocol
5. Patient with potential behavior and cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To establish the chemotherapeutic role of Curcumin in advanced head and neck cancers
2. To establish supportive role (enhancement of quality of life) in advanced head and neck cancer
3. To establish the modulation of proven biomarkers in advanced head and neck cancers with Curcumin
|
Baseline, 1st, 2nd, 4th, 6th & 8th week of treatment. Subsequently Quality of life assessment every two months until six month of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
13/08/2007 |
| 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="2"
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 establish the chemotherapeutic & supportive role of Curcumin in advanced head and neck cancers. It also aim to establish the modulation of proven biomarkers in advanced head and neck cancers with Curcumin. |