Cancer of Head and Neck
Conditions
Keywords
Soy, Isoflavone, Radiation Therapy, Cisplatin
Brief summary
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.
Detailed description
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.
Interventions
DRUGSoy isoflavone
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.
RADIATIONRadiation
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.
DRUGCisplatin
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
Sponsors
Radiation Therapy Oncology Group
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven squamous cell carcinoma of the head and neck (SCCHN) * Primary disease site involving the oropharynx * Clinical stage III or IV * Age ≥ 18 * Karnofsky Performance Status (KPS) ≥ 70 * Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit) * Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal
Exclusion criteria
* Prior history of SCCHN * Prior history of radiation to the head and neck region * KPS \< 70 * Soy allergy * Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy * Any head and neck cancer of non-squamous histology * Any head and neck subsite other than oropharynx (including unknown primary site) * Patients who are pregnant or lactating * Patients who may benefit from surgical resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment | 1 year after treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory biomarker studies: changes in interleukin 6 | 3 and 6 months post-treatment | Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment. |
| Exploratory biomarker studies: changes in vascular endothelial growth factor | 3 and 6 months post-treatment | Serum baseline levels of vascular endothelial growth factor (VEGF) and their levels at 3 and 6 months post-treatment. |
| Exploratory biomarker studies: changes in isoprostanes levels | 3 and 6 months post-treatment | Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation. |
Countries
United States
Outcome results
None listed