Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 4, 2007 |
| End Date: | September 17, 2014 |
Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer
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.
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.
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-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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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