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

NCT00929825 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Tania Mara Pimenta Amaral

    collaborator UNKNOWN

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Tarcilia A Silva, PhD · Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00929825 on ClinicalTrials.gov