Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors

NCT01504932 | Completed DMC

• 2 other identifiers: OSU-06132NCI-2011-03189
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.

Conditions

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

Keywords

black raspberry; Appalachia; oral cancer; cancer recurrence

Outcome Measures

Primary Outcomes (1)

• Time to recurrence

  Two side tests and confidence intervals will be constructed using the exact binomial formulation.

  Up to 5 years

Secondary Outcomes (4)

• Adherence rates in patients receiving LBR

  Up to 5 years

• LBR-responsive gene expression before, during, and after LBR administration (Arm I)

  Up to 5 years

• LBR-responsive gene expression in patients not exposed to LBR (Arm II)

  Up to 5 years

• LBR responsive gene activity and time to recurrence

  Up to 5 years

Study Arms (2)

Arm I: BRB Lozenge

EXPERIMENTAL

Former oral cancer patients receive lozenges containing freeze-dried black raspberry (BRB) powder. They will take the lozenges four times each day (QID) by mouth (PO) for up to 6 months. Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey. They will receive a trial-specific logbook to record their usages. Intervention: Black Raspberry (BRB) Lozenge Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis

Dietary Supplement: BRB Lozenge; Other: Survey Administration; Other: Laboratory Biomarker Analysis; Other: pharmacological study

Arm II: Biomarker Control

OTHER

Former oral cancer patients will not receive lozenges containing freeze-dried black raspberry (BRB) powder. Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey. They will receive a trial-specific logbook to record their usages. Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis

Other: Survey Administration; Other: Laboratory Biomarker Analysis; Other: pharmacological study

Interventions

BRB Lozenge DIETARY_SUPPLEMENT

ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.

Also known as: BRB Troche

Arm I: BRB Lozenge

Survey Administration OTHER

Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.

Also known as: HNCI Head and Neck Cancer Inventory, ISI Insomnia Severity Index, BFI Brief Fatigue Inventory

Arm I: BRB Lozenge; Arm II: Biomarker Control

Laboratory Biomarker Analysis OTHER

Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.

Also known as: Correlative Studies, Biological Samples

Arm I: BRB Lozenge; Arm II: Biomarker Control

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I: BRB Lozenge; Arm II: Biomarker Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Amit Agrawal, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: January 6, 2012
• Study Start: February 23, 2007
• Primary Completion: April 22, 2015
• Study Completion: April 22, 2015
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (1)