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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00431925
First received: February 5, 2007
Last updated: August 9, 2007
Last verified: February 2007
  Purpose

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
Oral Mucositis
Xerostomia
Weight Loss
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Can Cytokines Predict the Severity of Acute Mucositis and the Need for PEG During Chemo-Radiation Treatment to Head and Neck Cancer?

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 35
Estimated Study Completion Date: May 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431925

Contacts
Contact: Arik Tzukert, DMD 00 972 2 6777111 arik@hadassah.org.il

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Amichay Meirovitz, MD Hadassah Medical Organization
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00431925     History of Changes
Other Study ID Numbers: MucoCyt- HMO-CTIL
Study First Received: February 5, 2007
Last Updated: August 9, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
head and neck cancer
radiation therapy
chemotherapy
mucositis
cytokines
gastrostomy
radiotherapy

Additional relevant MeSH terms:
Salivary Gland Diseases
Head and Neck Neoplasms
Stomatitis
Weight Loss
Xerostomia
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014