Clinical trial NCT02007200: Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
Official title: A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2013-12-10
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

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.

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

Primary outcomes:
measure: Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
timeFrame: From baseline to surgery, up to 42 days
measure: Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
timeFrame: Up to 12 months
Secondary outcomes:
measure: The Number of Participants Alive at Follow-up
timeFrame: Up to 24 months
measure: The Number of Participants Alive Without Relapse at Last Follow-up
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Greg Wolf
role: PRINCIPAL_INVESTIGATOR
References: