Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: Laboratory Biomarker Analysis; Soy Isoflavones; Survey Administration
Intervention description: Correlative studies; Given PO; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 19 Years
Maximum age: 79 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of
             the oral cavity, oropharynx, larynx or hypopharynx

          -  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:

          -  Documented evidence of distant metastases

          -  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