Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2005
End Date:November 2010

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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.

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.

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.
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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