Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claire Verschraegen, University of Vermont
ClinicalTrials.gov Identifier:
NCT01252498
First received: December 2, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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


Condition
Cancer of the Head and Neck
Radiotherapy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Salivary levels of PGE2 and PGI2 during and after radiotherapy [ Time Frame: 10 weeks after initiation of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Observed mucositis during and after radiotherapy [ Time Frame: 10 weeks after initiation of radiotherapy ] [ Designated as safety issue: No ]
  • Patient reports of oral pain during and after radiation therapy [ Time Frame: 10 weeks after initiation of radiotherapy ] [ Designated as safety issue: No ]

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.


Enrollment: 9
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Radiotherapy
Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Claire Verschraegen, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01252498     History of Changes
Other Study ID Numbers: VCC1005
Study First Received: December 2, 2010
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014