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

Primary Purpose

Mucositis

Status
Withdrawn
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
mechanical stimulation (Elastomers)
TENS
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis focused on measuring Salivary stimulation, Transplantation of hematopoietic stem cells, Hyperboloid, Transcutaneous Electrical Stimulation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Dentistry of Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Elastomers

TENS

Elastomers+TENS

No therapy (control)

Arm Description

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

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

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

Patients will not receive intervention

Outcomes

Primary Outcome Measures

Salivary flux

Secondary Outcome Measures

Full Information

First Posted
June 4, 2009
Last Updated
August 8, 2016
Sponsor
Federal University of Minas Gerais
Collaborators
Tania Mara Pimenta Amaral
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1. Study Identification

Unique Protocol Identification Number
NCT00929825
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The Hospital had the Unit of Stem cells Tranplantion suspended
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Tania Mara Pimenta Amaral

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Selection of patients to be subjected to the transplantation of hematopoietic stem cells; Implementation of a reference sialometry; Institution of therapy with mechanical and electrical sialogogue; Clinical examination, assessment of the occurrence of mucositis and obtention of saliva samples pre- and post-THSC; Qualitative analysis of saliva (turbidity, viscosity and color); Biochemical analysis of saliva; Statistical analysis of data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
Salivary stimulation, Transplantation of hematopoietic stem cells, Hyperboloid, Transcutaneous Electrical Stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elastomers
Arm Type
Experimental
Arm Description
Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day
Arm Title
TENS
Arm Type
Experimental
Arm 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
Arm Title
Elastomers+TENS
Arm Type
Experimental
Arm Description
Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli
Arm Title
No therapy (control)
Arm Type
No Intervention
Arm Description
Patients will not receive intervention
Intervention Type
Device
Intervention Name(s)
mechanical stimulation (Elastomers)
Intervention Description
The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Description
transcutaneous electrical stimulation
Primary Outcome Measure Information:
Title
Salivary flux
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarcilia A Silva, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry of Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais/Belo Horizonte
ZIP/Postal Code
31270-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 May;113(5):628-37. doi: 10.1016/j.oooo.2011.10.012. Epub 2012 Apr 12. Effect of salivary stimulation therapies on salivary flow and chemotherapy-induced mucositis: a preliminary study. Pimenta Amaral TM1, Campos CC, Moreira dos Santos TP, Leles CR, Teixeira AL, Teixeira MM, Bittencourt H, Silva TA.

Learn more about this trial

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

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