Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation|
- To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers. [ Time Frame: unknown ] [ Designated as safety issue: No ]
- To assess antioxidant capacity, nutritional biomarkers and nutritional risk of patients during and after concurrent radiation and chemotherapy. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
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.
|Study Start Date:||June 2005|
|Study Completion Date:||November 2010|
This is an observational study
Head and neck cancer patients receiving chemoradiation
The study will include 60, ≥18 year old patients (of both genders) with head and neck cancers receiving concurrent radiation and chemotherapy treatment. Patients with any pathologically proven head and neck squamous cell carcinoma, except those of the nasopharynx and sinus will be eligible, if there is no evidence of metastatic disease. Patients with previous chemotherapy or radiation treatment will be excluded. A Karnofsky performance status ≥60% or more is required. Patients with significant cardiac, chest or gastrointestinal comorbidities will be excluded, as will those who have had previous chemotherapy or radiation treatment. Patients may receive standard nutritional care, as needed.
This study will involve an examination of the patient to evaluate mucositis, collection blood samples for analysis of specific indicators of nutritional status and completion of questionnaire regarding food intake and functional status. Blood samples will be collected and brief questionnaires about diet and weight status will be completed at each of the three visits. Visits will occur before treatment begins, at the end of XRT treatment and 4-6 weeks after completion of XRT. Assessments for the presence and severity of mucositis and functional status (Karnofsky) will be done at each visit. All of the samples and data collection will be done at visits to clinic required for the patients' treatment. If it is necessary to obtain blood samples from the central venous catheter, this will be done using aseptic technique and will be performed by a nurse. In some instances, the information obtained as part of this project may be used to reduce side effects of therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577902
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Jean Hine, PhD||University of Arkansas|