ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01252498
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Claire Verschraegen, University of Vermont

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

Condition or disease
Cancer of the Head and Neck Radiotherapy

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.


Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : December 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Radiotherapy
Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer



Primary Outcome Measures :
  1. Salivary levels of PGE2 and PGI2 during and after radiotherapy [ Time Frame: 10 weeks after initiation of therapy ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   None Retained
Saliva will be collected at 4 time points before, during, immediately after, and several weeks after radiotherapy for head and neck cancer.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving radiotherapy or chemoradiotherapy for oral cancers. Consecutive patients will be invited to participate.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252498


Locations
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Claire Verschraegen, MD University of Vermont/Fletcher Allen Health Care

Responsible Party: Claire Verschraegen, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01252498     History of Changes
Other Study ID Numbers: VCC1005
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Claire Verschraegen, University of Vermont:
Cancer of the head and neck
Radiotherapy
Prostaglandins

Additional relevant MeSH terms:
Mucositis
Head and Neck Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Neoplasms