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Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer


N/A
21 Years
N/A
Open (Enrolling)
Both
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

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Trial Information

Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer


PRIMARY OBJECTIVES:

I. To conduct an initial clinical study utilizing a high risk and underserved Appalachian
population who are former oral cancer patients to determine the practicability of long-term
daily lyophilized black raspberry (LBR) (LBR lozenge) administration and to gain insights
into the potential prevention of recurrent oral cancer by LBR.

SECONDARY OBJECTIVES:

I. Evaluate numerous parameters (recruitment, tolerability, adherence to study guidelines,
collection of biological samples, and demographics) that will be helpful in designing a
future definitive, randomized, Phase II or III clinical trial structured to assess the
potential effects of long-term LBR administration.

II. Evaluate the temporal modulation of LBR-responsive gene expression that favor oral
cancer chemoprevention in "at risk" normal tissues before, during and after LBR
administration.

III. Assess the temporal modulation of LBR-responsive gene expression and biological levels
of fruit components in post-surgical oral cancer patients not exposed to LBR.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

ARM I: Patients receive lyophilized black raspberry lozenges orally (PO) 4 times daily (QID)
for 6 months.

ARM II: Patients do not receive lyophilized black raspberries lozenges.

After completion of study treatment, patients in Arm I are followed up for 5 years and
patients in Arm II are followed up for up to 1 year.


Inclusion Criteria:



- Patients from any Appalachian County with previously diagnosed, biopsy-proven,
surgically resected, oral squamous cell carcinoma (SCC) (stages T1 to T4), which
encompasses cancers of the oral cavity including lips, buccal mucosa, teeth, floor of
the mouth and gums and those of the oropharynx consisting of the base of the tongue,
soft palate, tonsillar area, and the posterior pharyngeal wall will be eligible

- Patients who have followed the advice of their physician and have been definitively
treated for their tumor by any method and are currently disease free will be eligible

- Patients may be enrolled as early as their first follow-up post-operative clinic
visit after their most recent surgery, but no more than 36 months post-surgery

- Patients must be able to take nutrition/medications orally

- No prior history of intolerance or allergy to berry or berry-containing products

Exclusion Criteria:

- History of intolerance (including hypersensitivity or allergy) to berry or
berry-containing products

- Patients who are actively receiving adjuvant therapy (radiation, chemotherapy) will
be excluded until such time as they have completed treatments

- Pregnant women; although there are no known adverse effects of black raspberries upon
the fetus, if patients become pregnant during period of LBR administration, then LBR
will be discontinued and patient will be removed from the study

- Inability to grant informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to recurrence

Outcome Description:

Two side tests and confidence intervals will be constructed using the exact binomial formulation.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Amit Agrawal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-06132

NCT ID:

NCT01504932

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage I Squamous Cell Carcinoma of the Oropharynx
  • Stage I Verrucous Carcinoma of the Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Oropharynx
  • Stage II Verrucous Carcinoma of the Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage III Verrucous Carcinoma of the Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Tongue Neoplasms
  • Carcinoma, Verrucous
  • Oropharyngeal Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210