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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer of the Head and Neck, Radiotherapy

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Salivary levels of PGE2 and PGI2 during and after radiotherapy

Outcome Time Frame:

10 weeks after initiation of therapy

Safety Issue:

No

Principal Investigator

Steven M Grunberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont/Fletcher Allen Health Care

Authority:

United States: Institutional Review Board

Study ID:

VCC1005

NCT ID:

NCT01252498

Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Cancer of the Head and Neck
  • Radiotherapy
  • Cancer of the head and neck
  • Radiotherapy
  • Prostaglandins
  • Head and Neck Neoplasms
  • Mucositis

Name

Location

Fletcher Allen Health CareBurlington, Vermont  05401