Busulfan Concentration in Saliva and Plasma, and Its Relationship With Salivary Changes and Mucositis in the Digestive Tract of Patients Submitted to Hematopoietic Stem Cell Transplantation

• ClinicalTrials.gov Identifier: NCT03492749
• Recruitment Status: Completed
• First Posted: April 10, 2018
• Last Update Posted: May 11, 2021
• Sponsor: Hospital Israelita Albert Einstein
• Information provided by (Responsible Party): Fernanda de Paula Eduardo, Hospital Israelita Albert Einstein

Study Description

Brief Summary:

Busulfan (Bu) has been widely used for the treatment of neoplastic and non-neoplastic hematological disturbances, with satisfactory results in terms of successful hematopoietic stem cell transplantation (HSCT). Individual monitoring of the Bu dosage, which is done by means of various blood sample collections, is necessary for the purpose of attaining ideal therapeutic levels and minimizing systemic toxicity. This procedure sometimes becomes costly to and uncomfortable for the patient. Saliva has been analyzed as a possible alternative fluid for this monitoring.

Condition or disease	Intervention/treatment
Bone Marrow Disease	Diagnostic Test: Saliva monitoring

Detailed Description:

The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT. Another question related to this project is with reference to the effects that the Bu concentration in saliva has on the mucosa of the digestive tract, particularly with regard to mucositis and salivary changes. Thus, the second objective of this project is to verify whether there is any association between salivary changes, cytological changes in the oral mucosa, degrees of mucositis and concentration of Bu in saliva. An analysis will be performed of the Bu concentration in saliva and in blood, as well as the salivary dosage of total proteins, albumin, amylase, antioxidant enzymes (superoxide dismutase, catalase, and glutathione reductase) and pro-inflammatory cytokines IL-1β, IL-6 and TNF-α. In addition, morphological analysis will be made, and rate of apoptosis of cells of the oral mucosa will be analyzed. If the efficacy of saliva for the individual adjustment of the dose of Bu is confirmed, this method could facilitate the dissemination of pharmacokinetic monitoring of this drug in chemotherapy and HSCT centers. In addition, it is expected that the results of the present project will allow establishment of the toxicity indicators of BU detected by analysis of saliva and the cells of the oral mucosa, thereby allowing the early adoption of preventive actions for reducing the frequency and severity of mucositis, a fact that may have a positive impact on the success of HSCT.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Busulfan Concentration in Saliva and Plasma, and Its Relationship With Salivary Changes and Mucositis in the Digestive Tract of Patients Submitted to Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: February 2020
• Actual Study Completion Date: August 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Group Busulfan; Patients submitted a Bone marrow transplantation with the busulfan chemotherapy in the conditioning. Saliva monitoring	Diagnostic Test: Saliva monitoring; The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT
Group no busulfan; Patients submitted a Bone marrow transplantation without busulfan chemotherapy in the conditioning.Saliva monitoring	Diagnostic Test: Saliva monitoring; The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT

Outcome Measures

Primary Outcome Measures :

1. descriptive Analysis salivar [ Time Frame: 2 years ]
   An analysis will be performed of the Bu concentration in saliva and in blood, as well as the salivary dosage of total proteins, albumin, amylase, antioxidant enzymes

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients submitted bone marrow transplantation

Criteria

Inclusion Criteria:

• Submitted a TCTH

Exclusion Criteria:

• No signed informed consent

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

• Responsible Party: Fernanda de Paula Eduardo, Dentist, Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT03492749
• Other Study ID Numbers: 2902-16
• First Posted: April 10, 2018
• Last Update Posted: May 11, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mucositis; Bone Marrow Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Hematologic Diseases