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

NCT00577902 | Completed

• 1 other identifier: IRB# 41011
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• To assess antioxidant capacity, nutritional biomarkers and nutritional risk of patients during and after concurrent radiation and chemotherapy.

Study Arms (1)

Observational

This is an observational study

Other: Observation

Interventions

Observation OTHER

Head and neck cancer patients receiving chemoradiation

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• Age over 18 years,
• Pathologically proven squamous cell carcinomas of the head and neck, except nasopharyngeal and sinus
• Concurrent radiation and chemotherapy (taxotere/carboplatin)
• Karnofsky score over60
• Must receive radiation (IMRT)/chemotherapy at UAMS
• No evidence of metastatic disease
• No significant cardiac, chest, gastrointestinal or renal morbidities
• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

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.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jean Hine, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: June 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

US (1)