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


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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.

Inclusion Criteria


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers.

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Jean Hine, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

IRB# 41011

NCT ID:

NCT00577902

Start Date:

June 2005

Completion Date:

November 2010

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • Carcinoma
  • Head and Neck Neoplasms
  • Mucositis
  • Carcinoma, Squamous Cell

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205