Head and Neck Cancer Clinical Trial
Official title:
Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation
Verified date | February 2016 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study is being conducted to define the specific nutritional biomarkers and nutritional risk during the course of chemoradiation therapy for cancers of the head and neck. This prospective, longitudinal observational study is focused on specific antioxidants and B vitamins. The ORAC was selected as an index of overall antioxidant capacity. We chose to evaluate antioxidant status because administering antioxidants has been shown to reduce chemotherapeutic agent toxicities.
Status | Completed |
Enrollment | 37 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Methodology. Patients presenting at the UAMS Head and Neck Clinic will be invited to
participate in this study according to the inclusion criteria listed: 1. Age over 18 years, 2. Pathologically proven squamous cell carcinomas of the head and neck, except nasopharyngeal and sinus 3. Concurrent radiation and chemotherapy (taxotere/carboplatin) 4. Karnofsky score over60 5. Must receive radiation (IMRT)/chemotherapy at UAMS 6. No evidence of metastatic disease 7. No significant cardiac, chest, gastrointestinal or renal morbidities 8. No previous chemotherapy or radiation If they are considered eligible and agree to participate, the patients will be registered and sign informed consent form. Radiation and chemotherapy will commence on the same day. IMRT is the only modality of radiation allowed. Blood samples will be collected and nutritional risk evaluated, using the Patient-Generated Subjective Global Assessment tool (PG-SGA). The PG-SGA and blood tests will be performed before, at the end of XRT treatment and four to six weeks after treatment is completed. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers. | unknown | No | |
Secondary | To assess antioxidant capacity, nutritional biomarkers and nutritional risk of patients during and after concurrent radiation and chemotherapy. | unknown | No |
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