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

This study has been withdrawn prior to enrollment.
(The Hospital had the Unit of Stem cells Tranplantion suspended)
Sponsor:
Collaborator:
Tania Mara Pimenta Amaral
Information provided by (Responsible Party):
Tarcilia Aparecida da Silva, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00929825
First received: June 4, 2009
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Mucositis
Device: mechanical stimulation (Elastomers)
Procedure: TENS
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Salivary flux [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2008
Estimated Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elastomers
Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day
Device: mechanical stimulation (Elastomers)
The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
Experimental: 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
Procedure: TENS
transcutaneous electrical stimulation
Experimental: Elastomers+TENS
Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli
Device: mechanical stimulation (Elastomers)
The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
Procedure: TENS
transcutaneous electrical stimulation
No Intervention: No therapy (control)
Patients will not receive intervention

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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929825

Locations
Brazil
Faculty of Dentistry of Federal University of Minas Gerais
Belo Horizonte, Minas Gerais/Belo Horizonte, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
Tania Mara Pimenta Amaral
Investigators
Principal Investigator: Tarcilia A Silva, PhD Federal University of Minas Gerais
  More Information

Responsible Party: Tarcilia Aparecida da Silva, Associate Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT00929825     History of Changes
Other Study ID Numbers: 0520  Not aplicable 
Study First Received: June 4, 2009
Last Updated: August 8, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: Yes
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.


Keywords provided by Federal University of Minas Gerais:
Salivary stimulation
Transplantation of hematopoietic stem cells
Hyperboloid
Transcutaneous Electrical Stimulation

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2016