Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 15, 2011
November 7, 2013
February 2007
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01504932 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer
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 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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • 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
    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
  • Experimental: Arm I: (LBR chemoprevention)
    Patients receive lyophilized black raspberry lozenges PO QID for 6 months.
    Interventions:
    • Drug: lyophilized black raspberry lozenge
    • Other: survey administration
    • Other: laboratory biomarker analysis
    • Other: pharmacological study
  • 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.
    Interventions:
    • Other: survey administration
    • Other: laboratory biomarker analysis
    • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504932
OSU-06132, NCI-2011-03189
Yes
Amit Agrawal, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Amit Agrawal, MD Ohio State University
Ohio State University Comprehensive Cancer Center
November 2013

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