Can Cytokines Predict the Severity of Acute Mucositis and the Need for Gastrostomy Tubes (PEG)?
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|ClinicalTrials.gov Identifier: NCT00431925|
Recruitment Status : Unknown
Verified February 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : February 6, 2007
Last Update Posted : August 10, 2007
Mucositis and xerostomia are the most common complications of head and neck (H&N) irradiation, and the combination of chemotherapy and radiation therapy is associated with a significantly higher rate of complications.
Mucositis usually develops during the second or third week of a course of standard radiotherapy, and the pain it causes peaks between the third and last week of treatment. The pain then persists for at least one month following the completion of therapy, and may be so overwhelming that it prevents patients from swallowing food and fluids. The patient is therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect, the use of gastrostomy tubes (PEG) has been shown to be beneficial.
Completion of the full course of irradiation, without interruption, is important for achieving best possible results in cancer of the H&N. It is therefore essential to identify and refer patients at risk to receive effective and timely nutritional intervention.
Since mucositis represents a clinical continuum which differs between patients, it is difficult to assess before-hand which patients will be at risk.
There is no simple laboratory tool available, which could predict which patients are susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding gastrostomy.
The first phase of mucositis, inflammation, results in the production of pro-inflammatory cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α).
In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in inflammatory conditions and are found in increased levels in blood and tissue fluid during inflammation, while anti-inflammatory cytokines are produced in a decreased manner.
The main purpose of this study is to find the best indicators and prognosticators of mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment, and to understand the cytokines balance mechanism of action.
Assuming there is a correlation between high cytokines levels during inflammation and the severity of radiation induced mucositis, finding these prognostic factors may help us predict during the first part of the treatment the need for PEG, placing it prior to the complications associated with severe mucositis on one hand, and avoiding unnecessary procedures on the other hand.
|Condition or disease|
|Oral Mucositis Xerostomia Weight Loss Head and Neck Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Observational Model:||Defined Population|
|Official Title:||Can Cytokines Predict the Severity of Acute Mucositis and the Need for PEG During Chemo-Radiation Treatment to Head and Neck Cancer?|
|Estimated Study Completion Date :||May 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431925
|Contact: Arik Tzukert, DMD||00 972 2 firstname.lastname@example.org|
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Amichay Meirovitz, MD||Hadassah Medical Organization|