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Completed

NCT Number: NCT01252498

Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

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

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Key information

Conditions

Cancer of the Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Salivary levels of PGE2 and PGI2 during and after radiotherapy

    Time frame: 10 weeks after initiation of therapy

Secondary outcomes

  1. Observed mucositis during and after radiotherapy

    Time frame: 10 weeks after initiation of radiotherapy

  2. Patient reports of oral pain during and after radiation therapy

    Time frame: 10 weeks after initiation of radiotherapy

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2010
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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