Trial Information

Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma 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.