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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03492749
Other study ID # 2902-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date August 2020

Study information

Verified date May 2021
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 70 Years
Eligibility Inclusion Criteria: - Submitted a TCTH Exclusion Criteria: - No signed informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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