Clinical trial NCT00929825: Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Mucositis
Keywords: Salivary stimulation
Transplantation of hematopoietic stem cells
Hyperboloid
Transcutaneous Electrical Stimulation
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Tania Mara Pimenta Amaral
First posted: 2009-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary flux
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Faculty of Dentistry of Federal University of Minas Gerais
state: Minas Gerais/Belo Horizonte
Study officials:
affiliation: Federal University of Minas Gerais
name: Tarcilia A Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: