Patients receive lyophilized black raspberries lozenge PO (8gms/day)

Patients receive Saliva Substitute placebo PO QID.

Patients receive lyophilized black raspberries Saliva Substitute PO (8gms/day).

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

placebo

laboratory biomarker analysis

questionnaire administration

chemoprevention

Ohio State University Medical Center

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

Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer

Use diaries and collection of "empties" over 6-month treatment period. Test both measures simultaneously using global test. Two measures tested individually at alpha=0.05 if global test is significant. First check for interaction effect between dose and delivery with double-sided test at alpha=0.01. If that isn't significant, use data from both doses to perform a double-sided alpha=0.05 on difference in compliance between delivery methods. Dose response effect in compliance also tested. Exploring for interaction effects with continued tobacco use vs not and oral cavity patients vs others.

A double-sided test at alpha=0.05 and a mean summary across the repeated measures to test the difference in delivery methods will be used. Relationship between diary compliance and empties records and the two berry components measures over time will be modeled. The critical statistical result from this analysis will be the degree to which the individual patient's trends in the compliance measures correlate with the trends for the two components measured. Interaction effects with continued tobacco use will also be checked.

Using qRT-PCR measurements for each of 8 genes. Multiple endpoint approach for each gene will be used. Linear mixed models will be used for the repeated measures. Global test at 0.05 to decide superior delivery method. Mean summary statistic across the repeated measures will be used. Interaction effect of dose and delivery tested. Test for interaction of tobacco use at 0.05. Proc Mixed used to estimate both within person (over time changes) and between person relationships across berry components and pathway measures.

Slopes of change (toward baseline) estimated. Hypothesis testing to rule out chance as explanation of changes toward baseline in the berry exposed groups. Relationship between sustainability and the delivery dose studied. Effects on sustainability of continued or changing tobacco use will be estimated. Measures during extended follow-up that are clear indicators of efficacy will be collected.

Amit Agrawal

Principal Investigator

Ohio State University Comprehensive Cancer Center

Squamous Cell Carcinoma of Mouth

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

preventative dietary intervention

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

A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma

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.

rubus bollei/kaaries

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

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

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