Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells

Mucositis Clinical Trial

Official title: Effects of Mechanical and Electrical Sialogogues in Stimulation of the Flow and Biochemical Composition of Saliva in Patients Transplanted With Hematopoietic Stem Cells

Status Withdrawn

Clinical Trial Summary

The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas, multiple myeloma, among others. Most patients who undergo the THSC usually have oral manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy. The most common complications are the reduction of salivary flow, mucositis and graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere with medical therapy, leading to systemic complications, affecting the prognosis and increasing the length of hospitalization of the patient and the costs of treatment. To date, there is no protocol that prevents the reduction of salivary flow and minimizes the occurrence of mucositis and GVHD in these patients. This study aims to verify the effectiveness of treatment with two sialogogues (Hyperboloid and TENS [transcutaneous electrical stimulation]) to restore the flow and biochemical composition of saliva in patients undergoing THSC myeloablative and non-myeloablative conditionating regime.

Clinical Trial Description

It will be included in the sample a total of 60 patients undergoing hematopoietic stem cell transplantation (THSC) at the Clinical Hospital. Patients will be randomly divided into four groups, each with 15 subjects: group I patients who will use only the mechanical sialogogue; group II patients who will make use of electrical sialogogue (TENS); group III patients who will make use of mechanical sialogogue associated with TENS and group IV patients who will not receive therapy (control).

The project will present the following experimental design:

1. Selection of patients to be subjected to the transplantation of hematopoietic stem cells;

2. Implementation of a reference sialometry;

3. Institution of therapy with mechanical and electrical sialogogue;

4. Clinical examination, assessment of the occurrence of mucositis and obtention of saliva samples pre- and post-THSC;

5. Qualitative analysis of saliva (turbidity, viscosity and color);

6. Biochemical analysis of saliva;

7. Statistical analysis of data. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis

• NCT number: NCT00929825
• Study type: Interventional
• Source: Federal University of Minas Gerais
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 2008
• Completion date: August 2011