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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00929825
• Other study ID #: 0520
• Secondary ID: Not aplicable
• Status: Withdrawn
• Phase: Phase 1
• First received: June 4, 2009
• Last updated: August 8, 2016
• Start date: February 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients submitted to THSC at Clinical Hospital of Federal University who underwent a myeloablative or a non-myeloablative conditioning regime

• Age over 16 years

• Oral mucosa intact on the first day of conditioning

• Ability to cooperate with treatment

Exclusion Criteria:

• Cases with no clinical follow up

• Patients who refuse to participate

• Patients with no ability to cooperate with treatment

Study Design

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

Related Conditions & MeSH terms

• Mucositis

Intervention

Device:
• mechanical stimulation (Elastomers)
The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals

Procedure:
• TENS
transcutaneous electrical stimulation

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry of Federal University of Minas Gerais	Belo Horizonte	Minas Gerais/Belo Horizonte

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Tania Mara Pimenta Amaral

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary flux		7 days	Yes