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Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy Clinical research trials and Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy. Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy clinical trial. Participants typically obtain the most effective healthcare available for their Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy  Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy
Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy
For Condition: Stomatitis
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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
Details: 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 signalling 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 stomatogenic chemotherapy will be invited to participate in this study during a regularly scheduled pre-treatment visit in the National Institute of Dental and Craniofacial Research Dental Clinic. 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.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 .
Total Enrollment: 282
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020133; 02-D-0133
Study Start Date: March 6, 2002
Record last reviewed: February 9, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031551
Other Stomatitis Studies:
1. Recombinant Human Keratinocyte Growth Factor to Reduce Oral Mucositis in Hematologic Malignancy Patients Undergoing Peripheral Blood Stem Cell Transplantation After Radiation and High-dose Chemotherapy
2. A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2
3. Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy
Related Studies:
Other Stomatitis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Etanercept Mouthwash to Treat Stomatitis and Oral Pain in Patients Receiving Chemotherapy
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