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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504932
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Agrawal, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE February 23, 2007
Actual Primary Completion Date April 22, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
Time to recurrence [ Time Frame: Up to 5 years ]
Two side tests and confidence intervals will be constructed using the exact binomial formulation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2018)
  • 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).
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
  • Adherence rates in patients receiving LBR [ Time Frame: Up to 5 years ]
  • LBR-responsive gene expression before, during, and after LBR administration (Arm I) [ Time Frame: Up to 5 years ]
  • LBR-responsive gene expression in patients not exposed to LBR (Arm II) [ Time Frame: Up to 5 years ]
  • LBR responsive gene activity and time to recurrence [ Time Frame: Up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Official Title  ICMJE Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Dietary Supplement: BRB Lozenge
    ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.
    Other Name: 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: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Study Arms  ICMJE
  • 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

    Interventions:
    • Dietary Supplement: BRB Lozenge
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
    • Other: pharmacological study
  • 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

    Interventions:
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
    • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
42
Original Actual Enrollment  ICMJE
 (submitted: January 3, 2012)
44
Actual Study Completion Date  ICMJE April 22, 2015
Actual Primary Completion Date April 22, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504932
Other Study ID Numbers  ICMJE OSU-06132
NCI-2011-03189 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amit Agrawal, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Agrawal, MD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP