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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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 |
- 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.
- 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: | August 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
3 troches 4x daily given PO
Other Name: LBR lozenge
Other: survey administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Arm II: (biomarker control)
Patients do not receive lyophilized black raspberries lozenges.
|
Other: survey administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
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 |
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| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| 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: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Mouth Neoplasms Tongue Neoplasms Carcinoma, Verrucous Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Head and Neck Neoplasms Neoplasms by Site Mouth Diseases Stomatognathic Diseases Tongue Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013