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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02007200
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007200


Locations
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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
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Principal Investigator: Greg Wolf University of Michigan Rogel Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02007200    
Obsolete Identifiers: NCT01028001
Other Study ID Numbers: NCI-2011-03618
NCI-2011-03618 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UMCC 2009.008 ( Other Identifier: University of Michigan Comprehensive Cancer Center )
UMCC 2009.008 ( Other Identifier: DCP )
P30CA046592 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2013    Key Record Dates
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site