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Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer


Phase 1/Phase 2
21 Years
N/A
Open (Enrolling)
Both
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 Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, 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 Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, 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 Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

Thank you

Trial Information

Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Define tolerability and potential adverse effects of long-term black raspberry administration of post-surgical HN cancer patients

Outcome Time Frame:

up to 2 years

Safety Issue:

Yes

Principal Investigator

Amit Agrawal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-07085

NCT ID:

NCT01469429

Start Date:

September 2007

Completion Date:

Related Keywords:

  • 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 Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • 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 Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • 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 Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Carcinoma
  • Laryngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases
  • Mouth Neoplasms
  • Tongue Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms
  • Hypopharyngeal Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Verrucous
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary
  • Salivary Gland Neoplasms
  • Lip Neoplasms
  • Paranasal Sinus Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210