Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
NCT01469429 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2020-02-20
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.
Conditions
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- Salivary Gland Squamous Cell Carcinoma
- Stage 0 Hypopharyngeal Cancer
- Stage 0 Laryngeal Cancer
- Stage 0 Lip and Oral Cavity Cancer
- Stage 0 Nasopharyngeal Cancer
- Stage 0 Oropharyngeal Cancer
- Stage 0 Paranasal Sinus and Nasal Cavity Cancer
- Stage I Salivary Gland Cancer
- Stage I Squamous Cell Carcinoma of the Hypopharynx
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Squamous Cell Carcinoma of the Nasopharynx
- Stage I Squamous Cell Carcinoma of the Oropharynx
- Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Salivary Gland Cancer
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Nasopharynx
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Salivary Gland Cancer
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Nasopharynx
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage III Verrucous Carcinoma of the Larynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IVA Salivary Gland Cancer
- Stage IVA Squamous Cell Carcinoma of the Larynx
- Stage IVA Oral Cavity Squamous Cell Carcinoma
- Stage IVA Squamous Cell Carcinoma of the Oropharynx
- Stage IVA Nasal Cavity and Paranasal Sinus Cancer
- Stage IVA Verrucous Carcinoma of the Larynx
- Stage IVA Verrucous Carcinoma of the Oral Cavity
- Stage IVB Salivary Gland Cancer
- Stage IVB Squamous Cell Carcinoma of the Larynx
- Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Oropharynx
- Stage IVB Oral Cavity Squamous Cell Carcinoma
- Stage IVB Verrucous Carcinoma of the Larynx
- Stage IVB Verrucous Carcinoma of the Oral Cavity
- Stage IVC Salivary Gland Cancer
- Stage IVC Squamous Cell Carcinoma of the Larynx
- Stage IVC Oral Cavity Squamous Cell Carcinoma
- Stage IVC Squamous Cell Carcinoma of the Oropharynx
- Paranasal Sinus and Nasal Cavity Squamous Cell Carcinoma
- Stage IVC Verrucous Carcinoma of the Larynx
- Stage IVC Verrucous Carcinoma of the Oral Cavity
- Tongue Cancer
Interventions
- OTHER
-
placebo
Receive lozenge placebo PO
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
questionnaire administration
Ancillary studies
- DRUG
-
chemoprevention
Receive LBR lozenge PO
- DRUG
-
chemoprevention
Receive LBR Saliva Substitute PO
- OTHER
-
placebo
Receive Saliva Substitute placebo PO
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Amit Agrawal · Ohio State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-04
- Primary Completion
- 2014-09-17
- Completion
- 2014-09-17
Countries
- United States
Study Locations
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