Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
NCT ID: NCT01469429
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2007-09-04
2014-09-17
Brief Summary
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Detailed Description
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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-term black raspberry administration in this patient cohort.
II. Determine the effects of dose and delivery vehicle on the degree of uptake of black raspberry components in target oral tissues of post-surgical HN cancer patients over time and determine the relationships between adherence/exposure data and uptake.
III. Determine the ability of black raspberries to modulate patterns of gene expression within key regulatory pathways in "at-risk normal" oral mucosa of post-surgical HN cancer patients that would favor the inhibition, delay or reversal of oral carcinogenesis.
IV. Determine the persistence of modulation of "berry-responsive genes" for 2 years following commencement of black raspberry treatment and preliminarily define rate of recurrence and second primary oral cancers in a former oral cancer patient sub-cohort.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive lozenge placebo orally (PO) four times daily (QID).
ARM II: Patients receive lyophilized black raspberries lozenge PO QID.
ARM III: Patients receive Saliva Substitute placebo PO QID.
ARM IV: Patients receive lyophilized black raspberries Saliva Substitute PO QID.
In all arms, treatment continues for 6 months. Oral cavity scrapings, blood, urine, and saliva samples are collected periodically for laboratory analyses.
After completion of study treatment, some patients are followed up at weeks 1-5 and then at 2, 6, 12, and 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (Lozenge placebo)
Patients receive lozenge placebo PO QID.
placebo
Receive lozenge placebo PO
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
Arm II (LBR lozenge)
Patients receive lyophilized black raspberries lozenge PO (8gms/day)
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
chemoprevention
Receive LBR lozenge PO
Arm III (Saliva Substitute placebo)
Patients receive Saliva Substitute placebo PO QID.
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
placebo
Receive Saliva Substitute placebo PO
Arm IV (LBR Saliva Substitute)
Patients receive lyophilized black raspberries Saliva Substitute PO (8gms/day).
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
chemoprevention
Receive LBR Saliva Substitute PO
Interventions
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placebo
Receive lozenge placebo PO
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
chemoprevention
Receive LBR lozenge PO
chemoprevention
Receive LBR Saliva Substitute PO
placebo
Receive Saliva Substitute placebo PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Amit Agrawal
Principal Investigator
Principal Investigators
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Amit Agrawal
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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Jamesline
Other Identifiers
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NCI-2011-03226
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-07085
Identifier Type: -
Identifier Source: org_study_id
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