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

Federal University of Minas Gerais

Status and phase: Withdrawn; Phase 1

Conditions: Mucositis

Treatments: Procedure: TENS; Device: mechanical stimulation (Elastomers)

Study type: Interventional

Funder types: Other

Identifiers

NCT00929825

0520

Not aplicable

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 4 patient groups

Elastomers

Experimental group

Description:

Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day

Treatment:

Device: mechanical stimulation (Elastomers)

TENS

Experimental group

Description:

TENS is a eletric stimuli that will be use in the skin near to parotid glands. Patients will receive TENS treatment as eletric salivary stimuli. Patients will receive TENS stimuli once a day for 15 days

Treatment:

Procedure: TENS

Elastomers+TENS

Experimental group

Description:

Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli

Treatment:

Device: mechanical stimulation (Elastomers)

Procedure: TENS

No therapy (control)

No Intervention group

Description:

Patients will not receive intervention