Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage 0 Hypopharyngeal Cancer, Stage 0 Laryngeal Cancer, Stage 0 Lip and Oral Cavity Cancer, Stage 0 Nasopharyngeal Cancer, Stage 0 Oropharyngeal Cancer, Stage 0 Paranasal Sinus and Nasal Cavity Cancer, Stage I Salivary Gland Cancer, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Nasopharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Salivary Gland Cancer, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Larynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage II Verrucous Carcinoma of the Larynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Nasal Cavity and Paranasal Sinus Cancer, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Oral Cavity Squamous Cell Carcinoma, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Paranasal Sinus and Nasal Cavity Squamous Cell Carcinoma, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

In brief

This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers.

Key facts

Study ID

NCT01469429

Run by

Ohio State University Comprehensive Cancer Center

People needed

70

Starts

2007-09-04

Expected to finish

2014-09-17

Last updated by the study team

2020-02-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible subjects includes all adult HN cancer patients who have been previously diagnosed with Stage 1-4 and in-situ squamous cell carcinoma within the past 36 months (mos); with or without further adjuvant therapy and have been determined to be disease free at the time of consent
• Patients must be able to take nutrition/medications orally
• Have no prior history of intolerance or allergy to berry or berry-containing products
• Patients taking cyclooxygenase (COX)-1/COX-2 inhibitors (Indomethacin, Ibuprofen, celebrex) chronically, herbal supplements, who cannot be taken off the medication/supplement due to their clinical condition are eligible to participate in the study but should document daily doses of these medications in their logbooks

You may not qualify if…

• History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
• Inability to take oral nutrition/liquids or history of aspiration pneumonia
• Pregnant women: Although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of lyophilized black raspberries (LBR) administration, then LBR will be discontinued and patient will be removed from the study; we should however emphasize, given this is a food based-study, that risks are likely extremely low even though a participant should become pregnant; as such, we are not recommending active contraception for women, but rather if participants become pregnant, that they notify their study doctor, and that they will likely be removed from study; there are no expected or logical risks if men were to father a child, and as such, no contraception will be recommended for men
• Inability to grant informed consent
• Strict Vegetarians will be excluded from the study; it was found that consuming one portion per day of fruit or vegetables resulted in a significant decrease in oral cancer incidence; in those persons consuming multiple portions each day, there was a 50% reduction in risk; we assume that strict vegetarians will consume multiple portions each day of foods with chemopreventive activity and therefore inclusion of these individuals would have a negative impact on the study; there are several reports in the literature that herbal or multivitamin/mineral supplements have no effect on oral cancer incidence

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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