| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (soy isoflavones) | Experimental | Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone | 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. | From baseline to surgery, up to 42 days |
| Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Alive at Follow-up | Overall survival at last follow-up will be determined. | Up to 24 months |
| The Number of Participants Alive Without Relapse at Last Follow-up | Relapse-free survival will be determined at the last follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Wolf | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| University of Michigan Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Soy Isoflavones) | Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery. 55 patients were enrolled. 3 of these patients did not receive treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Soy Isoflavones |
| Drug |
Given PO |
|
|
| Survey Administration | Other | Ancillary studies |
|
| Up to 24 months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Soy Isoflavones) | Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone | 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. | 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. | Posted | Mean | Full Range | Percent change | From baseline to surgery, up to 42 days |
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| Primary | Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF | 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. | 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. | Posted | Up to 12 months |
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| Secondary | The Number of Participants Alive at Follow-up | Overall survival at last follow-up will be determined. | 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. | Posted | Number | participants | Up to 24 months |
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| Secondary | The Number of Participants Alive Without Relapse at Last Follow-up | Relapse-free survival will be determined at the last follow-up visit. | 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. | Posted | Number | participants | Up to 24 months |
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55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Soy Isoflavones) | Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery. | 7 | 52 | 25 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary arrest, cause unknown (non-fatal) | Cardiac disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Infection, Lung | Infections and infestations |
| |||
| Infection, Wound | Infections and infestations |
| |||
| Pain, Bone | Musculoskeletal and connective tissue disorders |
| |||
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders |
| |||
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders |
| |||
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
| |||
| Lymphopenia | Blood and lymphatic system disorders |
| |||
| Platelets | Blood and lymphatic system disorders |
| |||
| Fatigue (asthenia, lethargy, malaise) | General disorders |
| |||
| Fever in the absence of neutropenia | General disorders |
| |||
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders |
| |||
| Weight gain | General disorders |
| |||
| Weight loss | General disorders |
| |||
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders |
| |||
| Flushing | Skin and subcutaneous tissue disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Hemorrhage, Esophagus | Vascular disorders |
| |||
| Hemorrhage, Oral Cavity | Vascular disorders |
| |||
| Infection, Blood | Infections and infestations |
| |||
| Infection, Neck NOS | Infections and infestations |
| |||
| Infection - Other | Infections and infestations |
| |||
| Infection, Skin (cellulitis) | Infections and infestations |
| |||
| Edema: head and neck | Vascular disorders |
| |||
| Edema: limb | Vascular disorders |
| |||
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders |
| |||
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders |
| |||
| Amylase | Metabolism and nutrition disorders |
| |||
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders |
| |||
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders |
| |||
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders |
| |||
| Cholesterol, serum-high (hypercholestremia) | Metabolism and nutrition disorders |
| |||
| Creatinine | Metabolism and nutrition disorders |
| |||
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders |
| |||
| Lipase | Metabolism and nutrition disorders |
| |||
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders |
| |||
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders |
| |||
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders |
| |||
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders |
| |||
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders |
| |||
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders |
| |||
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders |
| |||
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders |
| |||
| Extremity-upper (function) | Musculoskeletal and connective tissue disorders |
| |||
| Joint-function | Musculoskeletal and connective tissue disorders |
| |||
| Muscle weakness, Extraocular | Musculoskeletal and connective tissue disorders |
| |||
| Muscle weakness, facial | Musculoskeletal and connective tissue disorders |
| |||
| Muscle weakness, Whole Body | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders |
| |||
| Confusion | Nervous system disorders |
| |||
| Mood alteration, Depression | Nervous system disorders |
| |||
| Neurology - Other | Nervous system disorders |
| |||
| Neuropathy: sensory | Nervous system disorders |
| |||
| Pain, Abdomen NOS | Gastrointestinal disorders |
| |||
| Pain, Back | Musculoskeletal and connective tissue disorders |
| |||
| Pain, Face | General disorders |
| |||
| Pain, Head | Nervous system disorders |
| |||
| Pain, Neck | Musculoskeletal and connective tissue disorders |
| |||
| Pain, Oral | Gastrointestinal disorders |
| |||
| Pain, Throat | Gastrointestinal disorders |
| |||
| Pain - Other | General disorders |
| |||
| Aspiration | Respiratory, thoracic and mediastinal disorders |
| |||
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders |
| |||
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders |
| |||
| Intra-operative injury | Surgical and medical procedures |
| |||
| Syndromes - Other | General disorders |
| |||
| Vessel injury-vein | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory T. Wolf, M.D. | University of Michigan Comprehensive Cancer Center | 800-865-1125 | gregwolf@umich.edu |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| C562489 | Lymphoid Interstitial Pneumonia |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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