Clinical trial · Observational
Can Cytokines Predict the Severity of Acute Mucositis and the Need for Gastrostomy Tubes (PEG)?
Can Cytokines Predict the Severity of Acute Mucositis and the Need for PEG During Chemo-Radiation Treatment to Head and Neck Cancer?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (7)
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- BACKGROUNDNagler 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
- BACKGROUNDScully 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
- BACKGROUNDWood 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
- BACKGROUNDWhicher JT, Evans SW. Cytokines in disease. Clin Chem. 1990 Jul;36(7):1269-81. PMID 2197032
- BACKGROUNDPeterman 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
- BACKGROUNDBarak 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