Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors

February 18, 2020 updated by: Amit Agrawal, Ohio State University Comprehensive Cancer Center

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

This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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

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 BRB administration.

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

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

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

ARM I: Patients receive freeze-dried black raspberry lozenges orally (PO) 4 times daily (QID) for up to 6 months.

ARM II: Patients do not receive freeze-dried black raspberries lozenges.

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I: BRB Lozenge

Former oral cancer patients receive lozenges containing freeze-dried black raspberry (BRB) powder. They will take the lozenges four times each day (QID) by mouth (PO) for up to 6 months.

Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.

They will receive a trial-specific logbook to record their usages.

Intervention: Black Raspberry (BRB) Lozenge Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Dietary supplement: BRB Lozenge
ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.
Other Names:
  • BRB Troche
Other: Survey Administration
Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.
Other Names:
  • HNCI Head and Neck Cancer Inventory
  • ISI Insomnia Severity Index
  • BFI Brief Fatigue Inventory
Other: Laboratory Biomarker Analysis
Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.
Other Names:
  • Correlative Studies
  • Biological Samples
Other: Arm II: Biomarker Control

Former oral cancer patients will not receive lozenges containing freeze-dried black raspberry (BRB) powder.

Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.

They will receive a trial-specific logbook to record their usages.

Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Other: Survey Administration
Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.
Other Names:
  • HNCI Head and Neck Cancer Inventory
  • ISI Insomnia Severity Index
  • BFI Brief Fatigue Inventory
Other: Laboratory Biomarker Analysis
Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.
Other Names:
  • Correlative Studies
  • Biological Samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence
Time Frame: Up to 5 years
Two side tests and confidence intervals will be constructed using the exact binomial formulation.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence rates in patients receiving LBR
Time Frame: Up to 5 years
Adherence rates for subjects on LBR will be evaluated using 95% confidence intervals based on the exact binomial formulation (margins of error will be approximately 8% based on an expected compliance rate near 75% of subjects).
Up to 5 years
LBR-responsive gene expression before, during, and after LBR administration (Arm I)
Time Frame: Up to 5 years
Reverse transcriptase polymerase chain reaction (RT-PCR) data will be analyzed on the log scale using repeated measures analysis of variance (ANOVA) models and the Bonferroni correction to adjust for the multiple inference problem
Up to 5 years
LBR-responsive gene expression in patients not exposed to LBR (Arm II)
Time Frame: Up to 5 years
Reverse transcriptase polymerase chain reaction (RT-PCR) data will be analyzed on the log scale using repeated measures analysis of variance (ANOVA) models and the Bonferroni correction to adjust for the multiple inference problem.
Up to 5 years
LBR responsive gene activity and time to recurrence
Time Frame: Up to 5 years
RT-PCR data will be analyzed on the log scale using repeated measures ANOVA models and the Bonferroni correction to adjust for the multiple inference problem. Genes that show changes with berries will also be compared with to a control group of 30 subjects who refuse LBR treatment but agree to be included in biomarker studies and for whom baseline alcohol and smoking history will be available
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Amit Agrawal, MD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2007

Primary Completion (Actual)

April 22, 2015

Study Completion (Actual)

April 22, 2015

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-06132
  • NCI-2011-03189 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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