Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
|ClinicalTrials.gov Identifier: NCT02007200|
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
|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|
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.
I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.
II. To determine overall and relapse-free survival.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Treatment (soy isoflavones)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Other: Laboratory Biomarker Analysis
Drug: Soy Isoflavones
Other: Survey Administration
- 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.
- 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.
- The Number of Participants Alive at Follow-up [ Time Frame: Up to 24 months ]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 ]Relapse-free survival will be determined at the last follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007200
|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|
|Principal Investigator:||Greg Wolf||University of Michigan Cancer Center|