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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT02007200
First received: December 4, 2013
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
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
Other: Laboratory Biomarker Analysis
Drug: Soy Isoflavones
Other: Survey Administration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The Number of Participants Alive at Follow-up [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Overall survival at last follow-up will be determined.

  • The Number of Participants Alive Without Relapse at Last Follow-up [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Relapse-free survival will be determined at the last follow-up visit.


Enrollment: 55
Study Start Date: July 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Soy Isoflavones
Given PO
Other Names:
  • NovaSoy
  • Solgen 40
  • Soy Isoflavone
  • Soybean Isoflavone Mixture
Other: Survey Administration
Ancillary studies

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

Ages Eligible for Study:   19 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007200

Locations
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Greg Wolf University of Michigan Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02007200     History of Changes
Obsolete Identifiers: NCT01028001
Other Study ID Numbers: NCI-2011-03618  NCI-2011-03618  UMCC 2009.008  UMCC 2009.008  P30CA046592 
Study First Received: December 4, 2013
Results First Received: July 7, 2016
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on December 07, 2016