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NCT Number: NCT02007200

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

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.

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Key information

Conditions

Recurrent Hypopharyngeal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Lymphoid Interstitial Pneumonia Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial 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 Squamous Cell Carcinoma of Head and Neck 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 Stomatognathic Diseases Tongue Carcinoma Tongue Diseases Tongue Neoplasms

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Soy Isoflavones

Drug

Given PO

Other names: NovaSoy, Solgen 40, Soy Isoflavone, Soybean Isoflavone Mixture

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone

    Time frame: From baseline to surgery, up to 42 days

    The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

  2. Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF

    Time frame: Up to 12 months

    Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

Secondary outcomes

  1. The Number of Participants Alive at Follow-up

    Time frame: Up to 24 months

    Overall survival at last follow-up will be determined.

  2. The Number of Participants Alive Without Relapse at Last Follow-up

    Time frame: Up to 24 months

    Relapse-free survival will be determined at the last follow-up visit.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2013
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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