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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mucositis
• Intervention / Treatment: Device: mechanical stimulation (Elastomers); Procedure: TENS

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais/Belo Horizonte
    • Belo Horizonte, Minas Gerais/Belo Horizonte, Brazil, 31270-901
      • Faculty of Dentistry of Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Salivary flux	7 days

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Tania Mara Pimenta Amaral
• Investigators: Principal Investigator: Tarcilia A Silva, PhD, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Transcutaneous Electrical Stimulation; Salivary stimulation; Transplantation of hematopoietic stem cells; Hyperboloid
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 0520; Not aplicable

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.