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

NCT03492749 | Completed DMC

• 1 other identifier: 2902-16
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Marrow Disease

Outcome Measures

Primary Outcomes (1)

• descriptive Analysis salivar

  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

  2 years

Study Arms (2)

Group Busulfan

Patients submitted a Bone marrow transplantation with the busulfan chemotherapy in the conditioning. Saliva monitoring

Diagnostic Test: Saliva monitoring

Group no busulfan

Patients submitted a Bone marrow transplantation without busulfan chemotherapy in the conditioning.Saliva monitoring

Diagnostic Test: Saliva monitoring

Interventions

Saliva monitoring DIAGNOSTIC_TEST

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 Busulfan; Group no busulfan

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients submitted bone marrow transplantation

You may qualify if:

• Submitted a TCTH

You may not qualify if:

• No signed informed consent

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

MeSH Terms

Conditions

Bone Marrow Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 10, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share