CTRI Number |
CTRI/2018/03/012274 [Registered on: 01/03/2018] Trial Registered Prospectively |
Last Modified On: |
10/08/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of two drugs, Curcumin and Metformin in patients with history of head and neck squamous cell cancers |
Scientific Title of Study
|
Phase IIb/III study to determine efficacy of Curcumin and Metformin to reduce the incidence of second primary tumors of aero-digestive tract in patients with history of head and neck squamous cell carcinoma |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Moni Abraham Kuriakose |
Address |
Chief, Head and Neck Oncology, Mazumdar Shaw Medical Center, Narayana Health City,Bommasandra Industrial Area, Anekal Taluk,Bangalore.
Bangalore KARNATAKA 560099 India |
Phone |
9902776000 |
Fax |
|
Email |
makuriakose@gmail.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Moni Abraham Kuriakose |
Address |
Chief, Head and Neck Oncology, Mazumdar Shaw Medical Center, Narayana Health City,Bommasandra Industrial Area, Anekal Taluk,Bangalore.
Bangalore KARNATAKA 560099 India |
Phone |
9902776000 |
Fax |
|
Email |
makuriakose@gmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Anjana Muralidharan |
Address |
Mazumdar Shaw Medical Center, Narayana Health City,Bommasandra Industrial Area, Anekal Taluk,Bangalore.
Bangalore KARNATAKA 560099 India |
Phone |
8197463029 |
Fax |
|
Email |
anjana_muralidharan@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
National Cancer Grid (Department of Atomic Energy, Government of India),Room No 1231,12th Floor,Homi Bhabha Block,
Tata Memorial Centre,
Dr E Borges Road,
Parel,Mumbai 400012 |
|
Primary Sponsor
|
Name |
National Cancer Grid |
Address |
Department of Atomic Energy, Government of India |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 3 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Arvind Krishnamurthy |
Cancer Institute Adyar |
Head and Neck and Thoracic Oncology, No:38, Sardar Patel Road, Adyar Chennai |
9840448174
drarvindkrishnamurthy@gmail.com |
Dr Rajesh Kantharia |
Kailash Cancer Hospital and Research center |
Head and Neck Oncosurgery, Muni Seva Ashram, Goraj Vadodara |
02667268038
rajesh.kantharia@greenashram.org |
Dr Moni Abraham Kuriakose |
Mazumdar Shaw Medical Center |
Head and Neck Oncology, #258A, Bommasandra Industrial Area, Anekal Taluk Bangalore Rural |
9902776000
makuriakose@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 10 |
Name of Committee |
Approval Status |
HCG multispeciality ethics committee |
Approved |
Human Ethics Committee Regional Cancer Centre Thiruvananthapuram |
Approved |
IEC Malabar Cancer Centre |
Approved |
Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
Institutional Ethics Committee, Kailash Cancer Hospital and Research Centre |
Approved |
Narayana Health Medical Ethics Committee |
Approved |
Postgraduate Institute of Medical research Chandigarh Institutional Ethics Committee |
Approved |
Tata Medical Centre Institutional Review Board |
Approved |
Tata Memorial Hospital Institutional Ethics Committee |
Approved |
The Institutional Ethics Committee, Cancer Institute (W.I.A) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients who have had curative intent treatment for head and neck squamous cell carcinoma |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Curcumin Capsule |
1.2 gm once daily oral for 36 months |
Comparator Agent |
Curcumin Placebo |
1.2 gm once daily oral for 36 months |
Comparator Agent |
Metformin Placebo |
1 gm once daily oral for 36 months |
Intervention |
Metformin Tablet |
1 gm once daily oral for 36 months |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1.History of head and neck squamous cell carcinoma excluding that of paranasal sinuses and nasopharynx with stage no higher than T1/2/3, N0/1, M0 who were treated with curative-intent within three to twelve months prior to accrual for the study.
2.All patients must be free of disease and recovered from initial treatment related complications.
3.All patients must have undergone curative intent treatment within three to twelve months of randomization.
4.All patients must have had CT scan of head and neck and chest at base line (within six months prior to enrollment)
5.Patients must be at least 18 years of age.
6.All patients must sign an informed consent before enrolling in study.
7.Patients must be able and willing to return to the clinic at appropriately scheduled intervals.
8.Pre-menopausal and peri-menopausal women must be using adequate birth control methods and have a negative pregnancy test prior to entry.
9.Patients who have not taken supplements of retinol, beta carotene, vitamin E, Selenium or other chemopreventive therapy at least three months prior to the baseline visit and all toxicities have been fully resolved.
10.Karnofsky Performance Score above 80.
11.The subject meets the following laboratory eligibility criteria during a time not to exceed 4 weeks prior to randomization.
a.Hemoglobin level above or equal 10gm percentage.
b.WBC count greater than 3,000 mm3.
c.Platelets count greater than 100,000 m3.
d.Total bilirubin, AST (SGOT) and ALT (SGPT)less than or equal to 1.5 x ULN.
e.Serum creatinine less than or equal to 2 x ULN
12.The subject is willing and able to fully participate for the duration of the study.
13.If applicable, the subject has been counseled on smoking cessation and alcoholism.
|
|
ExclusionCriteria |
Details |
1.Female patients who are pregnant or lactating.
2.Presence of any active malignant diseases.
3.Unknown primary tumor of head and neck.
4.Patients with salivary gland malignancies
5.Subjects with unstable cardiac and renal diseases
6.Subject who are diagnosed and under treatment for diabetes.
7.Subjects who are greater than 80 years in age.
8.The subject will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study.
9.The subject has a history of hypersensitivity to Metformin.
10.Subject with estimated Glomerular Filtration Rate less than 40 mL/min.
11.The subject is, in the opinion of the Institutional Principal Investigator, not an appropriate candidate for study participation.
12.The subject participated in the study previously and was withdrawn
13.The subject has not recovered from the acute toxic effects of chemotherapy, immunotherapy, hormonal therapy, or radiation therapy.
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
|
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To determine the efficacy of curcumin and metformin to reduce the incidence of second primary tumors of aero-digestive tract following curative intent treatment of head and neck squamous cell carcinomas |
Every 3 months upto the incidence of second primary tumor |
|
Secondary Outcome
|
Outcome |
TimePoints |
(1)TherapeuticbenefitofCurcuminandMetformininlowering recurrenceofprimarytumor
(2)EfficacyofCurcuminandMetformintowardsregressionofexistingoralpremalignantlesions
orreductioninoccurrenceofnew lesions
(3)Evaluatesafety oflongterm useofCurcuminandMetformin
(4)Evaluatecomplianceoflongtermchemopreventioninthis patient population
(5)Todetermineclonalityoftheindextumorandsecondprimarytumor
(6)Todeterminefactorsresponsibleforthedevelopmentofsecondprimarytumor |
Every 3 months up to 3 years |
|
Target Sample Size
|
Total Sample Size="1500" Sample Size from India="1500" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
02/04/2018 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="6" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
Brief Summary
|
This trial is intended to determine the efficacy of curcumin and metformin to reduce the incidence of second primary tumors 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. |