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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

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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Other: Laboratory Biomarker Analysis
Drug: Soy Isoflavones
Other: Survey Administration
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

55 patients were enrolled. 3 of these patients did not receive treatment.

Period Title: Overall Study
Started 55
Completed 55
Not Completed 0
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
60
(26 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
12
  30.8%
Male
27
  69.2%
1.Primary Outcome
Title Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
Hide Description 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.
Time Frame From baseline to surgery, up to 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description:
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Overall Number of Participants Analyzed 39
Mean (Full Range)
Unit of Measure: Percent change
4.9
(-34.8 to 20.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Soy Isoflavones)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method Linear Repeated Measures Model
Comments [Not Specified]
2.Primary Outcome
Title Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF
Hide Description 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.
Time Frame Up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description:
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Number of Participants Alive at Follow-up
Hide Description Overall survival at last follow-up will be determined.
Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description:
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
29
4.Secondary Outcome
Title The Number of Participants Alive Without Relapse at Last Follow-up
Hide Description Relapse-free survival will be determined at the last follow-up visit.
Time Frame Up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description:
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
24
Time Frame [Not Specified]
Adverse Event Reporting Description 55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
 
Arm/Group Title Treatment (Soy Isoflavones)
Hide Arm/Group Description Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
All-Cause Mortality
Treatment (Soy Isoflavones)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Soy Isoflavones)
Affected / at Risk (%) # Events
Total   7/52 (13.46%)    
Cardiac disorders   
Cardiopulmonary arrest, cause unknown (non-fatal)  1/52 (1.92%)  1
Gastrointestinal disorders   
Nausea  1/52 (1.92%)  1
Infections and infestations   
Infection, Lung  1/52 (1.92%)  1
Infection, Wound  1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders   
Pain, Bone  1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary/Upper Respiratory - Other  1/52 (1.92%)  1
Acute Respiratory Distress Syndrome  1/52 (1.92%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Soy Isoflavones)
Affected / at Risk (%) # Events
Total   25/52 (48.08%)    
Blood and lymphatic system disorders   
Hemoglobin  2/52 (3.85%)  24
Leukocytes (total WBC)  1/52 (1.92%)  1
Lymphopenia  3/52 (5.77%)  4
Platelets  1/52 (1.92%)  1
Gastrointestinal disorders   
Anorexia  1/52 (1.92%)  1
Constipation  2/52 (3.85%)  2
Diarrhea  2/52 (3.85%)  2
Dysphagia (difficulty swallowing)  1/52 (1.92%)  1
Nausea  4/52 (7.69%)  4
Vomiting  1/52 (1.92%)  1
Pain, Abdomen NOS  3/52 (5.77%)  3
Pain, Oral  4/52 (7.69%)  4
Pain, Throat  1/52 (1.92%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  5/52 (9.62%)  5
Fever in the absence of neutropenia  1/52 (1.92%)  2
Weight gain  4/52 (7.69%)  5
Weight loss  3/52 (5.77%)  4
Pain, Face  1/52 (1.92%)  1
Pain - Other  1/52 (1.92%)  1
Syndromes - Other  1/52 (1.92%)  1
Infections and infestations   
Infection, Blood  1/52 (1.92%)  1
Infection, Neck NOS  1/52 (1.92%)  1
Infection - Other  1/52 (1.92%)  1
Infection, Skin (cellulitis)  1/52 (1.92%)  1
Metabolism and nutrition disorders   
AST, SGOT(serum glutamic oxaloacetic transaminase)  1/52 (1.92%)  1
Albumin, serum-low (hypoalbuminemia)  5/52 (9.62%)  6
Amylase  3/52 (5.77%)  4
Bilirubin (hyperbilirubinemia)  1/52 (1.92%)  1
Calcium, serum-high (hypercalcemia)  3/52 (5.77%)  4
Calcium, serum-low (hypocalcemia)  6/52 (11.54%)  11
Cholesterol, serum-high (hypercholestremia)  3/52 (5.77%)  4
Creatinine  2/52 (3.85%)  2
Glucose, serum-high (hyperglycemia)  10/52 (19.23%)  19
Lipase  5/52 (9.62%)  5
Magnesium, serum-high (hypermagnesemia)  3/52 (5.77%)  6
Magnesium, serum-low (hypomagnesemia)  5/52 (9.62%)  6
Phosphate, serum-low (hypophosphatemia)  3/52 (5.77%)  7
Potassium, serum-high (hyperkalemia)  2/52 (3.85%)  2
Potassium, serum-low (hypokalemia)  3/52 (5.77%)  5
Sodium, serum-high (hypernatremia)  1/52 (1.92%)  2
Sodium, serum-low (hyponatremia)  4/52 (7.69%)  6
Triglyceride, serum-high (hypertriglyceridemia)  8/52 (15.38%)  10
Musculoskeletal and connective tissue disorders   
Extremity-upper (function)  1/52 (1.92%)  1
Joint-function  1/52 (1.92%)  1
Muscle weakness, Extraocular  1/52 (1.92%)  1
Muscle weakness, facial  1/52 (1.92%)  1
Muscle weakness, Whole Body  1/52 (1.92%)  1
Musculoskeletal/Soft Tissue - Other  1/52 (1.92%)  1
Pain, Back  1/52 (1.92%)  1
Pain, Neck  1/52 (1.92%)  1
Nervous system disorders   
Confusion  1/52 (1.92%)  2
Mood alteration, Depression  1/52 (1.92%)  1
Neurology - Other  1/52 (1.92%)  1
Neuropathy: sensory  1/52 (1.92%)  1
Pain, Head  1/52 (1.92%)  1
Renal and urinary disorders   
Urinary retention (including neurogenic bladder)  2/52 (3.85%)  2
Respiratory, thoracic and mediastinal disorders   
Aspiration  1/52 (1.92%)  1
Bronchospasm, wheezing  1/52 (1.92%)  1
Cough  2/52 (3.85%)  2
Hypoxia  1/52 (1.92%)  1
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1/52 (1.92%)  1
Skin and subcutaneous tissue disorders   
Sweating (diaphoresis)  1/52 (1.92%)  1
Dermatology/Skin - Other  1/52 (1.92%)  1
Flushing  1/52 (1.92%)  1
Surgical and medical procedures   
Intra-operative injury  1/52 (1.92%)  1
Vascular disorders   
Hemorrhage, Esophagus  1/52 (1.92%)  1
Hemorrhage, Oral Cavity  1/52 (1.92%)  1
Edema: head and neck  2/52 (3.85%)  2
Edema: limb  3/52 (5.77%)  3
Vessel injury-vein  1/52 (1.92%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregory T. Wolf, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 800-865-1125
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 ( 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 Submitted: December 4, 2013
First Posted: December 10, 2013
Results First Submitted: July 7, 2016
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016