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Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer

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ClinicalTrials.gov Identifier: NCT01504932
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Amit Agrawal, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
This pilot clinical trial studies freeze-dried black raspberries in preventing oral cancer recurrence in high-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. Giving freeze-dried black raspberries may prevent oral cancer from forming

Condition or disease Intervention/treatment Phase
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 Drug: lyophilized black raspberry lozenge Other: survey administration Other: laboratory biomarker analysis Other: pharmacological study Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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

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 LBR administration.

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

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

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

ARM I: Patients receive lyophilized black raspberry lozenges orally (PO) 4 times daily (QID) for 6 months.

ARM II: Patients do not receive lyophilized black raspberries lozenges.

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
Actual Study Start Date : February 23, 2007
Actual Primary Completion Date : April 22, 2015
Actual Study Completion Date : April 22, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I: (LBR chemoprevention)
Patients receive lyophilized black raspberry lozenges PO QID for 6 months.
 Drug: lyophilized black raspberry lozenge
ARM I: Patients will be instructed to begin LBR administration and continue daily for 6 months.
Other Name: LBR lozenge

Other: survey administration
Patients will be asked to complete a baseline survey of family history of cancer and tobacco/alcohol and mouthwash usage, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) survey, and a Brief Fatigue Inventory (BFI) survey. They will then receive a logbook (specific for this trial)
Other Names:
  • HNCI
  • ISI
  • BFI

Other: laboratory biomarker analysis
Patients will be asked to do blood, urine, and saliva sample and a buccal scrape. These biological samples will be evaluated for the presence of LBR components (as a measure of compliance) and assessment of LBR responsive genes, respectively.
Other Names:
  • correlative studies
  • biological samples

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Arm II: (biomarker control)
Patients do not receive lyophilized black raspberries lozenges. Patients will be asked to complete a baseline survey of family history of cancer and tobacco/alcohol usage, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) survey, and a Brief Fatigue Inventory (BFI) survey.
 Other: survey administration
Patients will be asked to complete a baseline survey of family history of cancer and tobacco/alcohol and mouthwash usage, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) survey, and a Brief Fatigue Inventory (BFI) survey. They will then receive a logbook (specific for this trial)
Other Names:
  • HNCI
  • ISI
  • BFI

Other: laboratory biomarker analysis
Patients will be asked to do blood, urine, and saliva sample and a buccal scrape. These biological samples will be evaluated for the presence of LBR components (as a measure of compliance) and assessment of LBR responsive genes, respectively.
Other Names:
  • correlative studies
  • biological samples

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies


Outcome Measures
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Primary Outcome Measures :
  1. Time to recurrence [ Time Frame: Up to 5 years ]
    Two side tests and confidence intervals will be constructed using the exact binomial formulation.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504932


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Amit Agrawal, MD Ohio State University
More Information
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Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

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Responsible Party: Amit Agrawal, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01504932     History of Changes
Other Study ID Numbers: OSU-06132
NCI-2011-03189 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amit Agrawal, Ohio State University Comprehensive Cancer Center:
black raspberry lozenges
Appalachian
Oral Cancer

Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Mouth Neoplasms
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Mouth Diseases
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Tongue Diseases