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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  
Name  Address 
NIL   
 
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)  
Status 
Not Applicable 
 
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.
 

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