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Sponsored by: |
National Institute of Nursing Research (NINR) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00031551 |
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:
Condition | Intervention | Phase |
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Stomatitis Cancer |
Drug: Etanercept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury |
Estimated Enrollment: | 135 |
Study Start Date: | March 2002 |
Stomatitis is defined as inflammation of the mucous membranes of the oral cavity and oropharynx characterized by tissue erythema, edema, and atrophy, often progressing to ulceration. Stomatitis is a biologically complex, multifactorial, treatment-related oral condition experienced by many oncology patients, which often leads to a cascade of negative sequelae including oropharyngeal pain, critical treatment alterations or cessation, and decreased quality of life. The optimal treatment strategies for stomatitis have not been established. There is a critical need to examine the pathogenesis of and to evaluate interventions for stomatitis and related acute oropharyngeal pain in the randomized controlled clinical trial setting using valid and reliable stomatitis assessment tools to both advance the science of cancer treatment-related oral toxicities and improve patient care. Therefore, the purpose of this randomized controlled clinical trial is to elucidate the role of inflammation in stomatitis by testing the effects of a novel tumor necrosis factor (TNF) fusion protein etanercept, (Enbrel, Immunex Corporation, Seattle, WA) on the incidence and severity of stomatitis. The actions of this fusion protein, which binds specifically to TNF preventing its interaction with cellular receptors and altering the inflammatory cascade, may provide insight into the role of inflammation in stomatitis. An etanercept effect is defined as a prevention or amelioration of stomatitis and acute oropharyngeal pain and/or changes in levels of tissue mediators. If stomatitis is primarily a consequence of a mucosal inflammatory response, then we hypothesize that this oral condition will be responsive to binding of TNF(alpha). Elaboration of the role of inflammatory cell signaling associated with stomatitis and the effect of TNF(alpha) may elucidate the mechanisms related to the pathogenesis of stomatitis and to other mucosal conditions.
Patients who are scheduled to receive autologous or allogenic peripheral blood stem cell or bone marrow transplant will be invited to participate in this study during a regularly scheduled pre-treatment visit. Written informed consent will be obtained from all participants. Patients will be randomized to receive either etanercept mouthwash or placebo, which will both be administered by protocol schedule. Stomatitis and oropharyngeal pain will be measured at baseline and at specified post-chemotherapy time points corresponding with the predicted stomatitis onset, peak, and healing time course. TNF(alpha) levels in buccal mucosa, analyzed by reverse transcriptase polymerase chain reaction techniques, and blood levels of pro-inflammatory cytokines, growth factors, and inflammatory mediators will also be measured at baseline and at specified post-chemotherapy time points corresponding with the predicted stomatitis onset, peak, and healing time course.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, South Carolina | |
Greenville Community Clinical Oncology Program | Recruiting |
Greenville, South Carolina, United States |
Responsible Party: | National Institutes of Health ( Jane M. Fall-Dickson, Ph.D./National Institutes of Nursing Research ) |
Study ID Numbers: | 020133, 02-NR-0133 |
Study First Received: | March 7, 2002 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00031551 |
Health Authority: | United States: Federal Government |
Stomatitis Oropharyngeal Pain TNF Etanercept Bone Marrow Transplantation Stomatitis Chemotherapy |
Cancer Mouth Mucous Membranes Healthy Volunteer HV Normal Control |
Mouth Diseases Stomatitis Pain |
Healthy Stomatognathic Diseases TNFR-Fc fusion protein |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |