Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031551
Status:
TERMINATED
Last Update Posted:
2017-12-06
First Post:
2002-03-07
Brief Title:
Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Efficacy and Mechanisms of an Anti-Inflammatory Intervention for Chemotherapy Related Mucosal Injury
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was not feasible to recruit required sample size from two clinical sites
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study consisted of two parts the pilot study and the main study The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva plasma and mucosal epithelial cells in patients who have chemotherapy-related stomatitis
Main Study Description 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 cancer 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 andor 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 TNFalpha Elaboration of the role of inflammatory cell signaling associated with stomatitis and the effect of TNFalpha 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 TNFalpha 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
Main Study Description 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 cancer 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 andor 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 TNFalpha Elaboration of the role of inflammatory cell signaling associated with stomatitis and the effect of TNFalpha 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 TNFalpha 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
Detailed Description:
This study consisted of two parts the pilot study and the main study The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva plasma and mucosal epithelial cells in patients who have chemotherapy-related stomatitis
Main Study Description 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 cancer 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 Registered Trademark 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 andor 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 TNFa Elaboration of the role of inflammatory cell signaling associated with stomatitis and the effect of TNFa may elucidate the mechanisms related to the pathogenesis of stomatitis and to other mucosal conditions
Patients who are scheduled to receive autologous or allogeneic 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 25mg in 20cc mouthwash or placebo 20cc mouthwash 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 TNFa levels in buccal mucosa analyzed by real time 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
Main Study Description 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 cancer 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 Registered Trademark 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 andor 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 TNFa Elaboration of the role of inflammatory cell signaling associated with stomatitis and the effect of TNFa may elucidate the mechanisms related to the pathogenesis of stomatitis and to other mucosal conditions
Patients who are scheduled to receive autologous or allogeneic 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 25mg in 20cc mouthwash or placebo 20cc mouthwash 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 TNFa levels in buccal mucosa analyzed by real time 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-NR-0133 | OTHER | NIH CC | None |