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Can Cytokines Predict the Severity of Acute Mucositis and the Need for Gastrostomy Tubes (PEG)?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Hadassah Medical Organization

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Defined Population
Time Perspective: Prospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with H&N epithelial cancer (nasopharynx, oropharynx, oral cavity - tongue, buccal mucosae and palate, larynx and hypopharynx)
  • Treated with definitive chemo-radiation treatment and follow up
  • Male and female patients will be included, with an age ranging between 18- 85 years

Exclusion Criteria:

  • Soldiers, prisoners and pregnant women will be excluded.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00431925

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Contact: Arik Tzukert, DMD 00 972 2 6777111

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Amichay Meirovitz, MD Hadassah Medical Organization
Layout table for additonal information Identifier: NCT00431925    
Other Study ID Numbers: MucoCyt- HMO-CTIL
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: August 10, 2007
Last Verified: February 2007
Keywords provided by Hadassah Medical Organization:
head and neck cancer
radiation therapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Weight Loss
Neoplasms by Site
Body Weight Changes
Body Weight
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases