Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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