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.

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:

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled

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 autologous or allogeneic PBSCT/BMT protocols, and are willing to participate in this study concurrently.

b) able to understand and sign protocol consent or assent

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 (non-steroidal anti-inflammatory drugs, antihistamines, and steroids- with the exception of decadron that is commonly used as a antimetic in the PBSCT/BMT setting).

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

f) known hyoersensitivity or allergic reaction to etanercept

Special Instructions:

Currently Not Provided

Keywords:

Stomatitis

Oropharyngeal Pain

TNF

Etanercept

Bone Marrow Transplantation

Recruitment Keyword(s):

Stomatitis

Chemotherapy

Cancer

Mouth

Mucous Membranes

Healthy Volunteer

HV

Normal Control

Condition(s):

Stomatitis

Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Etanercept

Supporting Site:

National Institutes of Nursing Research

Contact(s):

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

Citation(s):

Seto BG, Kim M, Wolinsky L, Mito RS, Champlin R. Oral mucositis in patients undergoing bone marrow transplantation. Oral Surg Oral Med Oral Pathol. 1985 Nov;60(5):493-7.

Woo SB, Sonis ST, Monopoli MM, Sonis AL. A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients. Cancer. 1993 Sep 1;72(5):1612-7.

Dose AM. The symptom experience of mucositis, stomatitis, and xerostomia. Semin Oncol Nurs. 1995 Nov;11(4):248-55. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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