Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells
8. august 2016 opdateret af: Tarcilia Aparecida da Silva, Federal University of Minas Gerais
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minas Gerais/Belo Horizonte
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Belo Horizonte, Minas Gerais/Belo Horizonte, Brasilien, 31270-901
- Faculty of Dentistry of Federal University of Minas Gerais
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Elastomers
Patients will use hyperboloid as mechanical salivary stimuli.
Patients will chew hyperboloid 3 times a day
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The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
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Eksperimentel: 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
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transcutaneous electrical stimulation
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Eksperimentel: Elastomers+TENS
Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli
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The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
transcutaneous electrical stimulation
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Ingen indgriben: No therapy (control)
Patients will not receive intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Salivary flux
Tidsramme: 7 days
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7 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tarcilia A Silva, PhD, Federal University of Minas Gerais
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2008
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Forventet)
1. august 2011
Datoer for studieregistrering
Først indsendt
4. juni 2009
Først indsendt, der opfyldte QC-kriterier
29. juni 2009
Først opslået (Skøn)
30. juni 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0520
- Not aplicable
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
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