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A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma of Mouth

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Trial Information

A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma


PRIMARY OBJECTIVES:

I. To determine the relationship between the length of short-term lyophilized black
raspberries (LBR) administration to human oral cancer patients and the modulation, in oral
cavity tissues, of a subset of specific genes previously identified by us to be
"LBR-responsive" and associated with LBR's chemopreventive activity.

SECONDARY OBJECTIVES:

I. To evaluate the effects of LBR administration in humans on cell proliferation, apoptosis,
and angiogenesis in oral cavity tissues using various established biomarkers including Ki-67
or proliferating cell nuclear antigen (PCNA), caspase-3, vascular endothelial growth factor
(VEGF) or basic fibroblast growth factor (bFGF).

II. To assess the feasibility of administering lyophilized freeze-dried black raspberries in
oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral
cavity (compliance, tolerance, adverse events).


Inclusion Criteria:



- Patients with newly diagnosed, biopsy-proven previously untreated squamous cell
carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be
allowed if biopsy is performed and results of SCC confirmed on subsequent
histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of
LBR administration

- Patients must already be planned for surgical resection of their tumor (prior to
being considered eligible for this study)

- 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

- Known history of bleeding disorder or patient on systemic anticoagulation therapy
(i.e. coumadin, heparin) for purposes of the study biopsy

- 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

- Patients must not be planning to receive chemotherapy or radiation therapy prior to
their surgery or this will affect endpoint analysis and these patients will be
excluded from the study

- Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off
the medication due to their clinical condition will be excluded given that these
agents may interfere with biomarkers studied

- Vegetarians will be excluded from the study since we anticipate that this patient
population will have difficulty adhering to a low-phenolic diet (restricts basically
all plant-based foods)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relationship between the length of short-term LBR administration to human oral cancer patients and the modulation, in oral cavity tissues, of LBR-responsive genes

Outcome Description:

Statistical summaries of biopsy to surgery changes in quantitative real-time RT-PCR data made on the log scale (geometric mean of percent changes +/- s.e. expressed as a percentage).Confidence intervals produced and significance of the correlation between real-time RT-PCR values and period of treatment (i.e. time from biopsy to surgery) using Fisher's transformation of Spearman's rank correlation tested. Semi-quantitative IHC analyzed using an ordinal logistic model to determine significance of associations between period of treatment and change in staining from biopsy to surgery.

Outcome Time Frame:

up to 60 months

Safety Issue:

No

Principal Investigator

Amit Agrawal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0497

NCT ID:

NCT01465776

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of Mouth
  • SCC of the oral cavity
  • black raspberries
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell

Name

Location

Ohio State University Medical Center Columbus, Ohio  43210