Health Condition 1: null- Patients who have had curative intent treatment for head and neck squamous cell carcinoma
Conditions
Interventions
Intervention1: Curcumin Capsule: 1.2 gm once daily oral for 36 months
Intervention2: Metformin Tablet: 1 gm once daily oral for 36 months
Control Intervention1: Curcumin Placebo: 1.2 gm once daily ora
Sponsors
National Cancer Grid
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 carcinomasTimepoint: Every 3 months upto the incidence of second primary tumor | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)TherapeuticbenefitofCurcuminandMetformininlowering recurrenceofprimarytumor (2)EfficacyofCurcuminandMetformintowardsregressionofexistingoralpremalignantlesions orreductioninoccurrenceofnew lesions (3)Evaluatesafety oflongterm useofCurcuminandMetformin (4)Evaluatecomplianceoflongtermchemopreventioninthis patient population (5)Todetermineclonalityoftheindextumorandsecondprimarytumor (6)TodeterminefactorsresponsibleforthedevelopmentofsecondprimarytumorTimepoint: Every 3 months up to 3 years | — |
Countries
India
Contacts
Public ContactAnjana Muralidharan
Mazumdar Shaw Medical Center
Outcome results
None listed