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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BRB Lozenge
Survey Administration
Laboratory Biomarker Analysis
pharmacological study
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity focused on measuring black raspberry, Appalachia, oral cancer, cancer recurrence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm I: BRB Lozenge

Arm II: Biomarker Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence rates in patients receiving LBR
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).
LBR-responsive gene expression before, during, and after LBR administration (Arm I)
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
LBR-responsive gene expression in patients not exposed to LBR (Arm II)
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.
LBR responsive gene activity and time to recurrence
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

Full Information

First Posted
December 15, 2011
Last Updated
February 18, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01504932
Brief Title
Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Official Title
Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 23, 2007 (Actual)
Primary Completion Date
April 22, 2015 (Actual)
Study Completion Date
April 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
black raspberry, Appalachia, oral cancer, cancer recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: BRB Lozenge
Arm Type
Experimental
Arm Description
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
Arm Title
Arm II: Biomarker Control
Arm Type
Other
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
BRB Lozenge
Other Intervention Name(s)
BRB Troche
Intervention Description
ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.
Intervention Type
Other
Intervention Name(s)
Survey Administration
Other Intervention Name(s)
HNCI Head and Neck Cancer Inventory, ISI Insomnia Severity Index, BFI Brief Fatigue Inventory
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Other Intervention Name(s)
Correlative Studies, Biological Samples
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Time to recurrence
Description
Two side tests and confidence intervals will be constructed using the exact binomial formulation.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Adherence rates in patients receiving LBR
Description
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).
Time Frame
Up to 5 years
Title
LBR-responsive gene expression before, during, and after LBR administration (Arm I)
Description
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
Time Frame
Up to 5 years
Title
LBR-responsive gene expression in patients not exposed to LBR (Arm II)
Description
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.
Time Frame
Up to 5 years
Title
LBR responsive gene activity and time to recurrence
Description
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
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Agrawal, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

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

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