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

NCT00431925 | Unknown

• 1 other identifier: MucoCyt- HMO-CTIL
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Xerostomia; Weight Loss; Head and Neck Cancer

Keywords

head and neck cancer; radiation therapy; chemotherapy; mucositis; cytokines; gastrostomy; radiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Soldiers, prisoners and pregnant women will be excluded.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (7)

• Wong PC, Dodd MJ, Miaskowski C, Paul SM, Bank KA, Shiba GH, Facione N. Mucositis pain induced by radiation therapy: prevalence, severity, and use of self-care behaviors. J Pain Symptom Manage. 2006 Jul;32(1):27-37. doi: 10.1016/j.jpainsymman.2005.12.020.

  PMID: 16824982 BACKGROUND

• Nagler RM, Barak V, Nagler A. Short-term systemic effects of head and neck irradiation. Anticancer Res. 2000 May-Jun;20(3A):1865-70.

  PMID: 10928120 BACKGROUND

• Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy: part 1, pathogenesis and prophylaxis of mucositis. Head Neck. 2003 Dec;25(12):1057-70. doi: 10.1002/hed.10318.

  PMID: 14648865 BACKGROUND

• Wood K. Audit of nutritional guidelines for head and neck cancer patients undergoing radiotherapy. J Hum Nutr Diet. 2005 Oct;18(5):343-51. doi: 10.1111/j.1365-277X.2005.00632.x.

  PMID: 16150130 BACKGROUND

• Whicher JT, Evans SW. Cytokines in disease. Clin Chem. 1990 Jul;36(7):1269-81.

  PMID: 2197032 BACKGROUND

• Peterman A, Cella D, Glandon G, Dobrez D, Yount S. Mucositis in head and neck cancer: economic and quality-of-life outcomes. J Natl Cancer Inst Monogr. 2001;(29):45-51. doi: 10.1093/oxfordjournals.jncimonographs.a003440.

  PMID: 11694566 BACKGROUND

• Barak V, Kalickman I, Nisman B, Farbstein H, Fridlender ZG, Baider L, Kaplan A, Stephanos S, Peretz T. Changes in cytokine production of breast cancer patients treated with interferons. Cytokine. 1998 Dec;10(12):977-83. doi: 10.1006/cyto.1998.0378.

  PMID: 10049522 BACKGROUND

MeSH Terms

Conditions

Stomatitis; Xerostomia; Weight Loss; Head and Neck Neoplasms; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Amichay Meirovitz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arik Tzukert, DMD

CONTACT

00 972 2 6777111; arik@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 6, 2007
• Study Completion: May 1, 2011
• Last Updated: August 10, 2007

Record last verified: 2007-02

Locations

IL (1)