Status:
COMPLETED
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Salivary Gland Squamous Cell Carcinoma
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the adherence of post-surgical head and neck (HN) cancer patients to clinical trial design expectations and define tolerability and potential adverse effects of long-...
Eligibility Criteria
Inclusion
- Eligible subjects includes all adult HN cancer patients who have been previously diagnosed with Stage 1-4 and in-situ squamous cell carcinoma within the past 36 months (mos); with or without further adjuvant therapy and have been determined to be disease free at the time of consent
- Patients must be able to take nutrition/medications orally
- Have no prior history of intolerance or allergy to berry or berry-containing products
- Patients taking cyclooxygenase (COX)-1/COX-2 inhibitors (Indomethacin, Ibuprofen, celebrex) chronically, herbal supplements, who cannot be taken off the medication/supplement due to their clinical condition are eligible to participate in the study but should document daily doses of these medications in their logbooks
Exclusion
- History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
- Inability to take oral nutrition/liquids or history of aspiration pneumonia
- Pregnant women: Although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of lyophilized black raspberries (LBR) administration, then LBR will be discontinued and patient will be removed from the study; we should however emphasize, given this is a food based-study, that risks are likely extremely low even though a participant should become pregnant; as such, we are not recommending active contraception for women, but rather if participants become pregnant, that they notify their study doctor, and that they will likely be removed from study; there are no expected or logical risks if men were to father a child, and as such, no contraception will be recommended for men
- Inability to grant informed consent
- Strict Vegetarians will be excluded from the study; it was found that consuming one portion per day of fruit or vegetables resulted in a significant decrease in oral cancer incidence; in those persons consuming multiple portions each day, there was a 50% reduction in risk; we assume that strict vegetarians will consume multiple portions each day of foods with chemopreventive activity and therefore inclusion of these individuals would have a negative impact on the study; there are several reports in the literature that herbal or multivitamin/mineral supplements have no effect on oral cancer incidence
Key Trial Info
Start Date :
September 4 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01469429
Start Date
September 4 2007
End Date
September 17 2014
Last Update
February 20 2020
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210