Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01252498

Enrollment

Registered

2010-12-03

Start date

2010-12-31

Completion date

2012-09-30

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Head and Neck, Radiotherapy

Keywords

Cancer of the head and neck, Radiotherapy, Prostaglandins

Brief summary

This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.

Detailed description

Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis. The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels. Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx * Receiving radiation therapy or chemoradiation therapy to the oropharynx * Older than 18 years old * ECOG performance status of 0-2 * Life expectancy greater than 2 months * Signed informed consent

Exclusion criteria

* Previous chemotherapy for this malignancy * Previous radiotherapy to the head and neck * Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer * Patient taking NSAIDs

Design outcomes

Primary

Measure	Time frame
Salivary levels of PGE2 and PGI2 during and after radiotherapy	10 weeks after initiation of therapy

Secondary

Measure	Time frame
Observed mucositis during and after radiotherapy	10 weeks after initiation of radiotherapy
Patient reports of oral pain during and after radiation therapy	10 weeks after initiation of radiotherapy

Countries

United States

Outcome results