drugset / Trial / NCT01469429
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
RandomizedParallel-groupOpen-labelPrevention
Summary
This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers.
Timeline
- Start
- 2007-09-04
- Primary completion
- 2014-09-17
- Completion
- 2014-09-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lyophilized black raspberries | Unknown | 8 g | Oral |
Indications
carcinoma in situ of hypopharynx
carcinoma in situ of nasopharynx
carcinoma in situ of oropharynx
hypopharynx squamous cell carcinoma
larynx carcinoma in situ
larynx verrucous carcinoma
metastatic squamous cell carcinoma
nasal cavity and paranasal sinus squamous cell carcinoma
nasopharyngeal squamous cell carcinoma
oral cavity carcinoma in situ
oropharynx squamous cell carcinoma
salivary gland squamous cell carcinoma
tongue cancer
verrucous carcinoma of oral cavity