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A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

Phase 2
19 Years
80 Years
Open (Enrolling)
Squamous Carcinoma

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Trial Information

A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

The overall long term goal of the proposed research is to determine if administration of a
soy isoflavone will provide a basis for secondary prevention and cancer control that can
decrease tumor recurrence and increase overall survival and quality of life in patients with
head and neck squamous carcinoma. Secondarily, we hope to identify candidate genes and
intermediate endpoints for future primary prevention trials. The inclusion of Karmanos
Cancer Institute and Emory University will provide additional new patient accrual and
improved access to minority patients.

We will conduct a Phase II trial to determine whether short term (3 weeks) soy isoflavone
administration can modulate p16 methylation and tissue expression of p53, p16, EGFR, VEGF,
Bcl-xL and COX-2 in resected specimens and adjacent non-tumor mucosa to potentially identify
markers useful as intermediate endpoints and define how quickly changes in gene markers
might be seen. Correlation of pretreatment tissue markers with serum and saliva markers will
be determined to identify potential surrogates of tissue markers that could be useful in
serial monitoring protocols in patients or high risk populations with oral leukoplakia or
dysplasia where serial tumor specimens are not available. This protocol is designed to
provide a comprehensive assessment of adjuvant soy isoflavone and molecular markers in a
prospective clinical trial setting. Accrual will be enhanced by the addition of Karmanos
Cancer Institute and Emory University.

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.

- ECOG Performance status 0-2 (See Appendix A).

- Patients must give documented informed consent to participate in this study.

- Age greater than 18 or less than 80.

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 patients with a history of breast or ovarian cancer.

- Allergy to soy products.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if preoperative (300 mg/day x 21 days) soy isoflavone modulates p16 methylation and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and Bcl-xL in tumor/non-tumor mucosa in patients with head/neck squamous carcinoma undergoing tumor resection.

Outcome Time Frame:

6 months, 12 months

Safety Issue:


Principal Investigator

Gregory T. Wolf, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2009.008



Start Date:

February 2010

Completion Date:

December 2016

Related Keywords:

  • Squamous Carcinoma
  • Stage I, II, III or IVa squamous cell carcinoma
  • oral cavity
  • oropharynx
  • larynx
  • hypopharynx
  • resectable
  • Head and Neck Squamous Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752