Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
NCT02007200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2016-10-24
Summary
This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.
Conditions
- Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Verrucous Carcinoma
- Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
- Recurrent Oral Cavity Verrucous Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Stage I Hypopharyngeal Squamous Cell Carcinoma
- Stage I Laryngeal Squamous Cell Carcinoma
- Stage I Laryngeal Verrucous Carcinoma
- Stage I Lip and Oral Cavity Squamous Cell Carcinoma
- Stage I Oral Cavity Verrucous Carcinoma
- Stage I Oropharyngeal Squamous Cell Carcinoma
- Stage II Hypopharyngeal Squamous Cell Carcinoma
- Stage II Laryngeal Squamous Cell Carcinoma
- Stage II Laryngeal Verrucous Carcinoma
- Stage II Lip and Oral Cavity Squamous Cell Carcinoma
- Stage II Oral Cavity Verrucous Carcinoma
- Stage II Oropharyngeal Squamous Cell Carcinoma
- Stage III Hypopharyngeal Squamous Cell Carcinoma
- Stage III Laryngeal Squamous Cell Carcinoma
- Stage III Laryngeal Verrucous Carcinoma
- Stage III Lip and Oral Cavity Squamous Cell Carcinoma
- Stage III Oral Cavity Verrucous Carcinoma
- Stage III Oropharyngeal Squamous Cell Carcinoma
- Stage IV Hypopharyngeal Squamous Cell Carcinoma
- Stage IVA Laryngeal Squamous Cell Carcinoma
- Stage IVA Laryngeal Verrucous Carcinoma
- Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
- Stage IVA Oral Cavity Verrucous Carcinoma
- Stage IVA Oropharyngeal Squamous Cell Carcinoma
- Tongue Carcinoma
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Soy Isoflavones
Given PO
- OTHER
-
Survey Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Greg Wolf · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- United States
Study Locations
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