Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery

NCT01465776 | Completed DMC

• 2 other identifiers: OSU-0497NCI-2011-02684
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer

Conditions

Squamous Cell Carcinoma of Mouth

Keywords

SCC of the oral cavity; black raspberries

Outcome Measures

Primary Outcomes (1)

• Relationship between the length of short-term LBR administration to human oral cancer patients and the modulation, in oral cavity tissues, of LBR-responsive genes

  Statistical summaries of biopsy to surgery changes in quantitative real-time RT-PCR data made on the log scale (geometric mean of percent changes +/- s.e. expressed as a percentage).Confidence intervals produced and significance of the correlation between real-time RT-PCR values and period of treatment (i.e. time from biopsy to surgery) using Fisher's transformation of Spearman's rank correlation tested. Semi-quantitative IHC analyzed using an ordinal logistic model to determine significance of associations between period of treatment and change in staining from biopsy to surgery.

  up to 60 months

Secondary Outcomes (2)

• Evaluate effects of lyophilized freeze-dried black raspberries (LBR) administration in humans on cell proliferation, apoptosis, and angiogenesis in oral cavity tissues using various established biomarkers.

  up to 60 months

• Assess feasibility of administering lyophilized freeze-dried black raspberries in oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral cavity.

  from 7-28 days

Study Arms (1)

Treatment (chemoprevention)

EXPERIMENTAL

Other: laboratory biomarker analysis; Other: preventative dietary intervention

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemoprevention)

preventative dietary intervention OTHER

lyophilized black raspberries(LBR) administration: 3 LBR troche lozenges (dissolved in mouth), 4 times/day beginning at minimum of 24 hrs following biopsy until night before surgery

Also known as: dietary, LBR, lyophilized black raspberries

Treatment (chemoprevention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed, biopsy-proven previously untreated squamous cell carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be allowed if biopsy is performed and results of SCC confirmed on subsequent histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of LBR administration
• Patients must already be planned for surgical resection of their tumor (prior to being considered eligible for this study)
• 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
• Known history of bleeding disorder or patient on systemic anticoagulation therapy (i.e. coumadin, heparin) for purposes of the study biopsy
• 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
• Patients must not be planning to receive chemotherapy or radiation therapy prior to their surgery or this will affect endpoint analysis and these patients will be excluded from the study
• Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off the medication due to their clinical condition will be excluded given that these agents may interfere with biomarkers studied
• Vegetarians will be excluded from the study since we anticipate that this patient population will have difficulty adhering to a low-phenolic diet (restricts basically all plant-based foods)

Sponsors & Collaborators

• Amit Agrawal: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Knobloch TJ, Uhrig LK, Pearl DK, Casto BC, Warner BM, Clinton SK, Sardo-Molmenti CL, Ferguson JM, Daly BT, Riedl K, Schwartz SJ, Vodovotz Y, Buchta AJ Sr, Schuller DE, Ozer E, Agrawal A, Weghorst CM. Suppression of Proinflammatory and Prosurvival Biomarkers in Oral Cancer Patients Consuming a Black Raspberry Phytochemical-Rich Troche. Cancer Prev Res (Phila). 2016 Feb;9(2):159-71. doi: 10.1158/1940-6207.CAPR-15-0187. Epub 2015 Dec 23.

  PMID: 26701664 BACKGROUND

Related Links

• Jamesline

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Diet

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amit Agrawal

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: November 7, 2011
• Study Start: January 10, 2005
• Primary Completion: February 16, 2010
• Study Completion: February 16, 2010
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

US (1)