CTRI/2018/03/012274
Recruiting
Phase 2
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
ational Cancer Grid0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients who have had curative intent treatment for head and neck squamous cell carcinoma
- Sponsor
- ational Cancer Grid
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\.
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.
Outcomes
Primary Outcomes
Not specified
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