Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amit Agrawal, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01465776
First received: September 8, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer


Condition Intervention Phase
Squamous Cell Carcinoma of Mouth
Other: laboratory biomarker analysis
Other: preventative dietary intervention
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate effects of lyophilized freeze-dried black raspberries (LBR) administration in humans on cell proliferation, apoptosis, and angiogenesis in oral cavity tissues using various established biomarkers. [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]
    Biomarkers include Ki-67, PCNA, caspase-3, VEGF, or bFGF

  • Assess 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. [ Time Frame: from 7-28 days ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: January 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemoprevention) Other: laboratory biomarker analysis
Correlative studies
Other: preventative dietary intervention
lyophilized black raspberries(LBR) administration: 3 LBR troche lozenges (dissolved in mouth), 4 times/day beginning at minimum of 24 hrs following biopsy until night before surgery
Other Names:
  • dietary
  • LBR
  • lyophilized black raspberries

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465776

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Amit Agrawal
Investigators
Principal Investigator: Amit Agrawal Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Amit Agrawal, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01465776     History of Changes
Other Study ID Numbers: OSU-0497, NCI-2011-02684
Study First Received: September 8, 2011
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
SCC of the oral cavity
black raspberries

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014