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

NCT ID: NCT00929825

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-08-31

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.

Conditions

Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TENS

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

Group Type: EXPERIMENTAL

TENS

Intervention Type: PROCEDURE

transcutaneous electrical stimulation

Elastomers+TENS

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

Group Type: EXPERIMENTAL

mechanical stimulation (Elastomers)

Intervention Type: DEVICE

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

TENS

Intervention Type: PROCEDURE

transcutaneous electrical stimulation

No therapy (control)

Patients will not receive intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Elastomers

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

Group Type: EXPERIMENTAL

mechanical stimulation (Elastomers)

Intervention Type: DEVICE

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

Interventions

mechanical stimulation (Elastomers)

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

Intervention Type: DEVICE

TENS

transcutaneous electrical stimulation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tania Mara Pimenta Amaral

UNKNOWN

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Tarcilia Aparecida da Silva

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarcilia A Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Faculty of Dentistry of Federal University of Minas Gerais

Belo Horizonte, Minas Gerais/Belo Horizonte, Brazil

Countries

Brazil

Other Identifiers

Not aplicable

Identifier Type: -

Identifier Source: secondary_id

0520

Identifier Type: -

Identifier Source: org_study_id