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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00577902
First received: December 18, 2007
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Other: Observation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: June 2005
Study Completion Date: November 2010
Groups/Cohorts Assigned Interventions
Observational
This is an observational study
Other: Observation
Head and neck cancer patients receiving chemoradiation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577902

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Jean Hine, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: R. Jean Hine, University of Arkansas
ClinicalTrials.gov Identifier: NCT00577902     History of Changes
Other Study ID Numbers: IRB# 41011
Study First Received: December 18, 2007
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
head and neck cancer

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Mucositis
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on April 17, 2014