Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation
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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 |
- 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 ]
- 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 |
Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:
Methodology. Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:
- 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.
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| 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 May 23, 2013