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.
