CTRI Number	CTRI/2018/03/012459 [Registered on: 12/03/2018] Trial Registered Retrospectively
Last Modified On:	06/03/2018
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Nutraceutical
Study Design	Single Arm Study
Public Title of Study Modification(s)	A study to assess the effect of Resveratrol and Copper in reducing toxic side-effects of chemotherapy in patients with advanced mouth cancer.
Scientific Title of Study	A study to assess the effect of Resveratrol-Copper (R-Cu) on levels of inflammatory cytokines in blood and tumour tissue in patients with operable stage IV squamous cell carcinoma of buccal mucosa
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Professor Dr Indraneel Mittra  Address  3rd Floor, Paymaster Shodhika Building Department of Surgical Oncology Advanced Centre for Treatment, Research and Education in Cancer Kharghar, Navi Mumbai-410210 Raigarh MAHARASHTRA 410210 India  Phone  912227405136   Fax  912227405061   Email  indraneel.mittra@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Professor Dr Indraneel Mittra  Address  3rd Floor, Paymaster Shodhika Building Department of Surgical Oncology Advanced Centre for Treatment, Research and Education in Cancer Kharghar, Navi Mumbai-410210 Raigarh MAHARASHTRA 410210 India  Phone  912227405136   Fax  912227405061   Email  indraneel.mittra@gmail.com
Details Contact Person Public Query Modification(s)	Name  Professor Dr Indraneel Mittra  Address  3rd Floor, Paymaster Shodhika Building Department of Surgical Oncology Advanced Centre for Treatment, Research and Education in Cancer Kharghar, Navi Mumbai-410210 Raigarh MAHARASHTRA 410210 India  Phone  912227405136   Fax  912227405061   Email  indraneel.mittra@gmail.com
Source of Monetary or Material Support	TMC Research Administrative Council, Department of Atomic Energy, Government of India; Tata Memorial Centre; Parel. Mumbai. India. PIN:400011
Primary Sponsor	Name  TMC Research Administrative Council  Address  Department of Atomic Energy, Government of India; Tata Memorial Centre; Parel. Mumbai. India. PIN:400011  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Professor Dr Indraneel Mittra  Tata Memorial Hospital  Room No.307 3rd Floor, Paymaster Shodhika Building Department of Surgical Oncology Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Kharghar, Navi Mumbai-410210 Raigarh   912227405136 912227405085 indraneel.mittra@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  TMC-IEC III  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Operable stage IV squamous cell carcinoma of buccal mucosa patients planned for surgery who have not received any prior treatment.
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Not applicable  Not applicable  Intervention  Trans-Resveratrol (Trade name – TransMaxTR) and Copper (Trade name – Chelated Copper)  Trans-Resveratrol is available as a health supplement in capsule form (500mg) and is approved for human use. It is available online from Biotivia LLC, USA and is recommended for oral use. The recommended human dose of Resveratrol as a health supplement is 500mg twice a day. Copper for human use is available as health supplement in tablet form (5mg). It is available online from J.R. Carlson Laboratories Inc. USA and is recommended for oral use. The recommended human dose of Cu as a health supplement is 5mg once a day. Commercially available honey will be used as the vehicle for resveratrol, while copper will be dissolved in water at requisite concentration.
Inclusion Criteria	Age From  18.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1. Male or female patients 18 years and above. 2. Patients who have given written informed consent 3. Patients with performance status of 0,1 or 2 (ECOG scale) 4. Treatment naïve operable stage IV squamous cell carcinoma of buccal mucosa patients planned for surgery.
ExclusionCriteria	Details  Medical comorbidities like hypertensive, diabetes mellitus, HbsAg and HIV positive, etc.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  To determine the effect of R-Cu on serum and tumour tissue levels of inflammatory cytokines and circulating chromatin at pre-defined time points in patients with operable stage IV squamous cell carcinoma of buccal mucosa prior to surgery.  2 weeks prior to surgery (Day 0) and then after 7 days (Day 7) and then after 14 days (Day 14).
Secondary Outcome	Outcome  TimePoints  Not applicable  Not applicable
Target Sample Size	Total Sample Size="25" Sample Size from India="25"
Phase of Trial	N/A
Date of First Enrollment (India)	19/06/2017
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details	None
Brief Summary	Patients with stage IV squamous cell carcinoma of buccal mucosa have elevated levels of inflammatory cytokines which are associated with disease progression and poor prognosis. We have reported that inflammatory cytokines are induced by DNA damage inflicted by cell-free chromatin. Therefore, treatments which will reduce cell-free chromatin may bring down cytokine levels and retard disease progression. We have discovered that a combination of resveratrol (R) and copper (Cu) can degrade cell-free chromatin and may be an effective means of reducing inflammatory cytokines. The present study is designed to determine the most optimal dose and ratios of R and Cu in human subjects with head and neck cancer. R and Cu will be administered separately – one after the other. The former being water insoluble will be administered in honey, while copper will be administered dissolved in water. Twenty five patients would be recruited and divided into 5 groups who will receive the following treatments: 1.    Only honey and water (1 tablespoon each twice a day) – first 5 patients 2.    5.6 mg of R and 560 ng of Cu (R:Cu ratio 1:10,000; wt for wt) – 6th to 10th patients. 3.    50mg of R and 5µg of Cu (R:Cu ratio 1:10,000; wt for wt) –11th to 15th patients. 4.    500mg of R and 50µg of Cu (R:Cu ratio 1:10,000; wt for wt) –16th to 20th patients. 5.   500mg of R and 5mg of Cu (one capsule each of R and Cu) (R:Cu ratio 1:100; wt for wt) –21st to 25th patients. This is the recommended dose for resveratrol and copper as health supplements.