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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

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date March 6, 2018
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 Complete list of historical versions of study NCT01504932 on ClinicalTrials.gov Archive Site
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-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer
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 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
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 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
  • 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
Study Arms  ICMJE
  • 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
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: January 3, 2012)
44
Original Actual Enrollment  ICMJE Same as current
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 Device Product: 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 March 2018

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