Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RAD2412-13 | Other Identifier | Winship Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Radiation Therapy Oncology Group | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.
Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy isoflavone | Experimental | Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy isoflavone | Drug | Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment | The primary outcome of this study is the percentage of patients with symptomatic (grade 2 or higher) xerostomia at 1 year post-treatment, assessed by the Late Effects of Normal Tissues (LENT)/Subjective, Objective, Management, Analytic (SOMA) method. | 1 year after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarker studies: changes in interleukin 6 | Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment. | 3 and 6 months post-treatment |
| Exploratory biomarker studies: changes in vascular endothelial growth factor |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristin Higgins, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Winship Cancer Institute |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| D019833 | Genistein |
| D011827 | Radiation |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiation | Radiation | All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day. |
|
| Cisplatin | Drug | Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment. |
|
|
Serum baseline levels of vascular endothelial growth factor (VEGF) and their levels at 3 and 6 months post-treatment. |
| 3 and 6 months post-treatment |
| Exploratory biomarker studies: changes in isoprostanes levels | Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation. | 3 and 6 months post-treatment |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| 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 |
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |