Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
This study is currently recruiting participants.
Verified May 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Amit Agrawal, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01469429
First received: October 27, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVA Squamous Cell Carcinoma of the Oropharynx Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity 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 Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity 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 Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVC Squamous Cell Carcinoma of the Oropharynx Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IVC Verrucous Carcinoma of the Larynx Stage IVC Verrucous Carcinoma of the Oral Cavity Tongue Cancer |
Other: placebo Other: laboratory biomarker analysis Other: questionnaire administration Drug: chemoprevention |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer |
Resource links provided by NLM:
Further study details as provided by Ohio State University Comprehensive Cancer Center:
Primary Outcome Measures:
- Define tolerability and potential adverse effects of long-term black raspberry administration of post-surgical HN cancer patients [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Effects of dose and delivery vehicle on the degree of uptake of black raspberry components in target oral tissues of post-surgical HN cancer patients over time and determine the relationships between adherence/exposure data and uptake. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Correlation between change in gene expression within key regulatory pathways and dose and delivery method [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]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.
- Sustainability of the measures within genes found to show significant berry effects beyond the 6-month exposure period [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm I (Lozenge placebo)
Patients receive lozenge placebo PO QID.
|
Other: placebo
Receive lozenge placebo PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
|
|
Experimental: Arm II (LBR lozenge)
Patients receive lyophilized black raspberries lozenge PO QID.
|
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Drug: chemoprevention
Receive LBR lozenge PO
Other Names:
|
|
Placebo Comparator: Arm III (Saliva Substitute placebo)
Patients receive Saliva Substitute placebo PO QID.
|
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: placebo
Receive Saliva Substitute placebo PO
Other Name: PLCB
|
|
Experimental: Arm IV (LBR Saliva Substitute)
Patients receive lyophilized black raspberries Saliva Substitute PO QID.
|
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Drug: chemoprevention
Receive LBR Saliva Substitute PO
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the adherence of post-surgical head and neck (HN) cancer patients to clinical trial design expectations and define tolerability and potential adverse effects of long-term black raspberry administration in this patient cohort.
II. Determine the effects of dose and delivery vehicle on the degree of uptake of black raspberry components in target oral tissues of post-surgical HN cancer patients over time and determine the relationships between adherence/exposure data and uptake.
III. Determine the ability of black raspberries to modulate patterns of gene expression within key regulatory pathways in "at-risk normal" oral mucosa of post-surgical HN cancer patients that would favor the inhibition, delay or reversal of oral carcinogenesis.
IV. Determine the persistence of modulation of "berry-responsive genes" for 2 years following commencement of black raspberry treatment and preliminarily define rate of recurrence and second primary oral cancers in a former oral cancer patient sub-cohort.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive lozenge placebo orally (PO) four times daily (QID).
ARM II: Patients receive lyophilized black raspberries lozenge PO QID.
ARM III: Patients receive Saliva Substitute placebo PO QID.
ARM IV: Patients receive lyophilized black raspberries Saliva Substitute PO QID.
In all arms, treatment continues for 6 months. Oral cavity scrapings, blood, urine, and saliva samples are collected periodically for laboratory analyses.
After completion of study treatment, some patients are followed up at weeks 1-5 and then at 2, 6, 12, and 18 months.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469429
Contacts
| Contact: Ohio State University Comprehensive Cancer Center | 1-800-296-5066 | Jamesline@osumc.edu |
| Contact: Amit Agrawal, MD | 614-293-8068 | Amit.Agrawal@osumc.edu |
Locations
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Ohio State University Comprehensive Cancer Cener 800-293-5066 jamesline@osumc.edu | |
| Contact: Amit Agrawal, MD 614-293-8074 Amit.Agrawal@osumc.edu | |
| Principal Investigator: Amit Agrawal, MD | |
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
| Principal Investigator: | Amit Agrawal | 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: | NCT01469429 History of Changes |
| Other Study ID Numbers: | OSU-07085, NCI-2011-03226, R01CA127368 |
| Study First Received: | October 27, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Paranasal Sinus Neoplasms Carcinoma Laryngeal Neoplasms Carcinoma, Squamous Cell Laryngeal Diseases Mouth Neoplasms Tongue Neoplasms Oropharyngeal Neoplasms Nasopharyngeal Neoplasms Hypopharyngeal Neoplasms Carcinoma in Situ Carcinoma, Verrucous Head and Neck Neoplasms Neoplasms, Unknown Primary Salivary Gland Neoplasms |
Lip Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Otorhinolaryngologic Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases Neoplasms, Squamous Cell Mouth Diseases Stomatognathic Diseases Tongue Diseases Pharyngeal Neoplasms Pharyngeal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013