Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
NCT ID: NCT02589860
Last Updated: 2022-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-10-30
2020-03-23
Brief Summary
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Detailed Description
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All study samples will be collected from participants while they are hospitalized to receive standard of care high-dose Melphalan (HDM) chemotherapy and autologous peripheral blood stem cell transplantation (ASCT). Patients who receive this treatment are typically admitted the day before HDM. The day after HDM, patients receive ASCT and remain hospitalized for approximately 21 days, or until their absolute neutrophil count increases to at least 500 cells per mm3 and they are no longer considered neutropenic.
Patients will have blood samples collected for pharmacokinetic analysis at approximately 0 minutes (before infusion begins), 15 minutes (during the infusion), 30 minutes (at the end of infusion), 60 minutes, 90 minutes, 120 minutes, and 180 minutes after the start of Melphalan infusion.
A buccal swab will be done to collect mucosal bacterial samples using paper strips (Periopaper) or a sterile cotton tipped swab brushed against the right and left buccal mucosa for approximately 15-30 seconds at the following time points:
1. Within 24 hours PRIOR to administration of Melphalan
2. Day +3 AFTER transplantation
3. Upon development of OM (approximately on days +7-10)
4. Upon recovery of absolute neutrophil count (ANC) to greater than 500/mm3, or on discharge, whichever occurs first, in patients who developed OM
A buccal scraping will be done for gene expression using a dermatologic curette taken from the right and left buccal mucosa at the following time points:
1. Within 24 hours PRIOR to administration of Melphalan
2. Day +3 AFTER transplantation Note: Patients' mouths will be rinsed with Mary's Magic mouthwash prior to the procedure for 15 seconds, which will allow for removal of food particles, colonized bacteria and anesthetization of oral mucosa. During procedure, any signs of patient discomfort will be monitored. If patient expresses discomfort, additional oral topical anesthetic will be utilized to de-sensitive buccal mucosa.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Melphalan kinetic study
Concentration of Melphalan in plasma samples
Oral bacterial study
DNA from oral buccal mucosal cells will be sequenced for bacterial composition
Gene expression study
RNA from oral buccal mucosal cells will be analyzed to compare gene expression
Eligibility Criteria
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Inclusion Criteria
2. Age is greater than 18 years old
3. Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen
4. No prior history of allogeneic stem cell transplantation
5. Patients otherwise meeting all standard institutional criteria for ASCT
18 Years
ALL
No
Sponsors
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Sherif S. Farag
OTHER
Responsible Party
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Sherif S. Farag
Professor of Medicine and Medical and Molecular Genetics
Principal Investigators
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Sheriff Farag, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine, Indiana University Simon Cancer Center
Locations
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Indiana University Health Hospital
Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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IUSCC-0536
Identifier Type: -
Identifier Source: org_study_id
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