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CompletedNCT01252498Updated Feb 4, 2014

Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

An observational study in Cancer of the Head and Neck and Radiotherapy, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-04.

Sponsored by University of Vermont · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer of the Head and Neck
  • Radiotherapy

Keywords

  • Cancer of the head and neck
  • Radiotherapy
  • Prostaglandins
03

In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's enrollment of 9 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Radiotherapy

    Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

06

What researchers measure

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

07

Study locations

1 site
  • Fletcher Allen Health Care
    Burlington, Vermont 05401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01252498
Responsible party
Claire Verschraegen (Professor of Medicine, University of Vermont) — Principal investigator
First posted
Dec 3, 2010
Start date
Dec 2010
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Feb 4, 2014

Study contacts

Claire Verschraegen, MD
principal investigator · University of Vermont/Fletcher Allen Health Care

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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