Protocol Number: 02-NR-0133

Title:

Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury

Number:

02-NR-0133

Summary:

This study will evaluate the safety and effectiveness of an etanercept (Enbrel) mouthwash in treating stomatitis-a condition that often develops in cancer patients receiving certain chemotherapy-and related pain. Stomatitis is an inflammation of the mucous membranes of the mouth and throat causing redness, swelling, and atrophy of tissues that may lead to ulceration, mouth and throat pain, and decreased quality of life. Etanercept is a new drug that has been approved in injection form for treating rheumatoid arthritis and associated pain.

Patients 16 years of age and older who are receiving chemotherapy under a National Cancer Institute protocol may be eligible for this study. The study may be expanded to include patients at the National Naval Medical Center, the Lombardi Cancer Center at Georgetown University Medical Center, and the Johns Hopkins Oncology Center. Normal volunteers will also be enrolled. Volunteers will be screened with a medical history and possibly a physical examination and blood tests.

Normal volunteers will have a port (small, thin plastic tube) placed in an arm vein for drawing blood (thus avoiding the need for multiple needle sticks). They will swish 4 teaspoons of an etanercept solution in their mouths for 30 seconds and then spit it out. Blood samples will be drawn 5 minutes before and 5 minutes after the rinse, and again 1, 2, 3, and 4 hours later. A total of 12 teaspoons of blood will be collected.

Patients will have the following tests and procedures:

- Dental clinic visit before chemotherapy followed by stem cell or bone marrow transplantation. This visit will include:

- Interview regarding current medications and use of alcohol and cigarettes

- Rating of mouth and throat pain

- Photographs of the inside of the mouth

- Examination of the teeth and gums

- Buccal brush biopsy - For this procedure, the inside of the cheek is brushed gently to collect cells, which will be examined for markers of inflammation.

- Etanercept or placebo treatment. Patients will be randomly assigned to swish 4 teaspoons of an etanercept solution or placebo (look-alike solution with no active ingredient) in their mouths for 30 seconds and then spit it out four times a day. They will start using the mouthwash the day before chemotherapy begins and stop when any stomatitis that has developed has healed and there is no oral or throat pain, or, when they are discharged from the hospital-whichever comes first.

- Treatment evaluations. Baseline (7 days before the stem cell or bone marrow transplant), 2 days before the transplant, at days 2, 5, 7, 9, 12, and 14 after the transplant, or at discharge from the hospital-whichever occurs first. Patients will be evaluated with:

- Rating of mouth and throat pain

- Photographs of the inside of the mouth and examination for stomatitis using a small light

- Buccal biopsy

- Blood sample collection, drawn through the central line during a regularly scheduled blood collection

Sponsoring Institute:

(NINR)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

a) Male or female oncology patients who are enrolled in the participating NCI stomatogenic chemotherapy protocols, and are willing to participate in this study concurrently.

b) able to understand and sign protocol consent or assent form.

c) age 16 years or older.

EXCLUSION CRITERIA:

a) Pregnant or lactating females;

b) unable to follow oral rinsing directions;

c) intubation;

d) chronic use of medications confounding assessment of the inflammatory response.

e) pre-existing oral infection, which might maximize the possibility of an infection or sepsis contributing to a drug-related adverse event .

Special Instructions: Currently Not Provided

Keywords:

Stomatitis

Oropharyngeal Pain

TNF

Etanercept

Bone Marrow Transplantation

Recruitment Keywords:

Stomatitis

Chemotherapy

Cancer

Mouth

Mucous Membranes

Healthy Volunteer

HV

Normal Control

Conditions:

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/19/2004