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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

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:
NCT01504932
First received: December 15, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Two side tests and confidence intervals will be constructed using the exact binomial formulation.


Secondary Outcome Measures:
  • Adherence rates in patients receiving LBR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • LBR-responsive gene expression before, during, and after LBR administration (Arm I) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • LBR-responsive gene expression in patients not exposed to LBR (Arm II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • LBR responsive gene activity and time to recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: February 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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: NCT01504932

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Amit Agrawal, MD 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: NCT01504932     History of Changes
Other Study ID Numbers: OSU-06132, NCI-2011-03189
Study First Received: December 15, 2011
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014