Oral cancer Cancer Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention agents (each 5 cups per day):
1. Green tea
2. Black tea
3. Caffeinated water
4. Placebo water
The tea (400 mg of tea powder per cup), caffeinated water (same concentration as
Sponsors
Georgetown University (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be aged 18 to 60 years 2. Potential subjects should have been smoking for at least two years and be currently smoking at least 1/2 pack (10 cigarettes) per day 3. Subjects should be, in general, on a low flavonoid diet (low plant-based diet)
Exclusion criteria
Exclusion criteria: 1. Allergic to tea or caffeine 2. Have oral leukoplakia or evidence of oral lesions 3. Regularly take medications containing caffeine, principally analgesics and 'cold' medicines (American Drug Index 1999) 4. Habitually drink more than two cups of coffee, tea, or caffeinated sodas per day 5. Habitually drink energy drinks (such as Red Bull, Jolt, Monster, etc.) each day 6. Drink more than two servings in one day of: 40% proof alcoholic beverages (3 oz), beer (12 oz), wine (6 oz), or any cocktail 7. Suffering from cancer 8. Have been treated with chemotherapy or radiotherapy within the past five years 9. Have cardiac arrhythmias or other heart disease or have been advised not to take excessive caffeine 10. Strict vegetarians 11. Taking alternative medications that have primarily an antioxidant effect (American Drug Index 1999) 12. Taking Vitamin A, C and E in doses > 1-1/2 x the RDA 13. Have serum levels of Vitamin A, serum carotenoids or alpha-tocopherol above the upper limits of normal 14. Have high blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Markers of DNA damage (8-OH guanine) 2. Tobacco carcinogen metabolites (cyclic adducts) 3. Apoptosis | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United States of America
Outcome results
None listed