Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
NCT ID: NCT02007200
Last Updated: 2016-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2009-07-31
2015-09-30
Brief Summary
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Detailed Description
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I. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16, cyclooxygenase 2 \[COX-2\], vascular endothelial growth factor receptor \[VEGF\], epidermal growth factor receptor \[EGFR\], interleukin-6 \[IL6\], p53 and B-cell lymphoma-extra large \[Bcl-xL\] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous carcinoma undergoing curative tumor resection.
II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.
SECONDARY OBJECTIVES:
I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.
II. To determine overall and relapse-free survival.
OUTLINE:
Patients receive soy isoflavones orally (PO) for approximately 14 days before undergoing surgery.
After completion of treatment, patients are followed up, within the routine cancer management schedule, at 3, 6, 12, and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Laboratory Biomarker Analysis
Correlative studies
Soy Isoflavones
Given PO
Survey Administration
Ancillary studies
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Soy Isoflavones
Given PO
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease must be Stage I, II, III or IVa
* Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Patients must give documented informed consent to participate in this study
Exclusion Criteria
* Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
* Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
* A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
* Patients residing in prison
* Any patient with a history of breast or ovarian cancer
* Allergy to soy products
19 Years
79 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Greg Wolf
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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NCI-2011-03618
Identifier Type: REGISTRY
Identifier Source: secondary_id
UMCC 2009.008
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2009.008
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-03618
Identifier Type: -
Identifier Source: org_study_id
NCT01028001
Identifier Type: -
Identifier Source: nct_alias
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