Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252498
• Other study ID #: VCC1005
• Status: Completed
• Phase: N/A
• First received: December 2, 2010
• Last updated: February 3, 2014
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms
• Radiotherapy

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary levels of PGE2 and PGI2 during and after radiotherapy		10 weeks after initiation of therapy	No
Secondary	Observed mucositis during and after radiotherapy		10 weeks after initiation of radiotherapy	No
Secondary	Patient reports of oral pain during and after radiation therapy		10 weeks after initiation of radiotherapy	No