NCT00929825

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

June 4, 2009

Last Update Submit

August 8, 2016

Conditions

Mucositis

Keywords

Salivary stimulationTransplantation of hematopoietic stem cellsHyperboloidTranscutaneous Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Salivary flux

    7 days

Study Arms (4)

Elastomers

EXPERIMENTAL

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

Device: mechanical stimulation (Elastomers)

TENS

EXPERIMENTAL

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

Elastomers+TENS

EXPERIMENTAL

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

Device: mechanical stimulation (Elastomers)Procedure: TENS

No therapy (control)

NO INTERVENTION

Patients will not receive intervention

Interventions

mechanical stimulation (Elastomers)DEVICE

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

ElastomersElastomers+TENS
TENSPROCEDURE

transcutaneous electrical stimulation

Elastomers+TENSTENS

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cases with no clinical follow up
  • Patients who refuse to participate
  • Patients with no ability to cooperate with treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry of Federal University of Minas Gerais

Belo Horizonte, Minas Gerais/Belo Horizonte, 31270-901, Brazil

Location

MeSH Terms

Conditions

Mucositis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Tarcilia A Silva, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 30, 2009

Study Start

February 1, 2008

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

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.

Locations

BR(1)