Trial record 4 of 125 for:    Open Studies | "Laryngeal Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT02007200
First received: December 4, 2013
Last updated: June 30, 2014
Last verified: June 2014
  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 Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage I Squamous Cell Carcinoma of the Hypopharynx
Stage I Squamous Cell Carcinoma of the Larynx
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Squamous Cell Carcinoma of the Oropharynx
Stage I Verrucous Carcinoma of the Larynx
Stage I Verrucous Carcinoma of the Oral Cavity
Stage II Squamous Cell Carcinoma of the Hypopharynx
Stage II Squamous Cell Carcinoma of the Larynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage II Verrucous Carcinoma of the Larynx
Stage II Verrucous Carcinoma of the Oral Cavity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Drug: soy isoflavones
Other: laboratory biomarker analysis
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:
  • Change in p16 methylation (% CpG sites methylated) and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and BclxL in tumor and non-tumor adjacent mucosa [ Time Frame: From baseline to surgery ] [ Designated as safety issue: No ]
    The change in the endpoints (p16 methylation and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and Bcl-xL) 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:
  • Overall survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Survival and relapse-free survival functions will be estimated using the product-limit (Kaplan-Meier) method, with appropriate confidence intervals, for the entire sample and for subsets defined by demographic and baseline clinical variables. In addition, proportional hazards (Cox) regression will be used to assess the potential of biomarker response to treatment as a predictor of survival and relapse-free survival. These analyses are strictly exploratory and hypothesis-generating.

  • Relapse-free survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Survival and relapse-free survival functions will be estimated using the product-limit (Kaplan-Meier) method, with appropriate confidence intervals, for the entire sample and for subsets defined by demographic and baseline clinical variables. In addition, proportional hazards (Cox) regression will be used to assess the potential of biomarker response to treatment as a predictor of survival and relapse-free survival. These analyses are strictly exploratory and hypothesis-generating.

  • Incidence of observed toxicities [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    Adverse events observed in the pre-operative and immediate (30 day) post-operative period will be tabulated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade and description, assessed relationship to treatment, and demographic and baseline clinical variables. The analyses will be descriptive and no hypothesis tests are planned.


Estimated Enrollment: 120
Study Start Date: July 2009
Estimated Primary Completion Date: December 2014 (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.
Drug: soy isoflavones
Given PO
Other Names:
  • NovaSoy
  • soy phytoestrogens
Other: laboratory biomarker analysis
Correlative studies
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
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 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Omer Kucuk    404-778-5903    okucuk@emory.edu   
Principal Investigator: Omer Kucuk         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Greg Wolf    734-936-9178    gregwolf@umich.edu   
Principal Investigator: Greg Wolf         
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: George H. Yoo    313-576-9782    yoog@karmanos.org   
Principal Investigator: George H. Yoo         
Sponsors and Collaborators
Investigators
Principal Investigator: Greg Wolf University of Michigan
  More Information

No publications provided

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
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Laryngeal Diseases
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Tongue Neoplasms
Carcinoma, Verrucous
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Respiratory Tract Neoplasms
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014