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

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Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929825
Enrollment
0
Registered
2009-06-30
Start date
2008-02-29
Completion date
2011-08-31
Last updated
2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

Keywords

Salivary stimulation, Transplantation of hematopoietic stem cells, Hyperboloid, Transcutaneous Electrical Stimulation

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.

Interventions

DEVICEmechanical stimulation (Elastomers)

The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals

PROCEDURETENS

transcutaneous electrical stimulation

Sponsors

Tania Mara Pimenta Amaral
CollaboratorUNKNOWN
Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Salivary flux7 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026