MucositisPhase 1NCT00929825
Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells
A Phase 1 study testing mechanical stimulation (Elastomers) and TENS in people with Mucositis, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucositis
- What is being tested?
- mechanical stimulation (Elastomers) and TENS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cases with no clinical follow up
- Patients who refuse to participate
- Patients with no ability to cooperate with treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry of Federal University of Minas Gerais
Belo Horizonte, Minas Gerais/Belo Horizonte, 31270-901
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Mucositis
- Being tested
- mechanical stimulation (Elastomers), TENS
- Keywords
- Salivary stimulation, Transplantation of hematopoietic stem cells, Hyperboloid, Transcutaneous Electrical Stimulation
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical stimulation (Elastomers)Device
The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
TENSProcedure or surgery
transcutaneous electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Elastomers | Experimental | Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day Receives: 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 Receives: Procedure: TENS |
| Elastomers+TENS | Experimental | Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli Receives: Device: mechanical stimulation (Elastomers); Procedure: TENS |
| No therapy (control) | No intervention | Patients will not receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary flux
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionAug 2011 (estimated)
Why it stopped: The Hospital had the Unit of Stem cells Tranplantion suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Tania Mara Pimenta Amaral
- Responsible party
- Principal investigator, Tarcilia Aparecida da Silva, Federal University of Minas Gerais
- Investigators
- Tarcilia A Silva, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929825
- Sponsor's protocol ID
- 0520
- Other IDs
- Not aplicable
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2009
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00929825
- Acronym / sponsor ID
- 0520
- Conditions
- Mucositis
- Keywords
- Salivary stimulation, Transplantation of hematopoietic stem cells, Hyperboloid, Transcutaneous Electrical Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Hospital had the Unit of Stem cells Tranplantion suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Tania Mara Pimenta Amaral
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (estimated)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elastomers | Experimental | Device: mechanical stimulation (Elastomers)Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day |
| TENS | Experimental | Procedure: TENSTENS 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 |
| Elastomers+TENS | Experimental | Device: mechanical stimulation (Elastomers), Procedure: TENSPatients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli |
| No therapy (control) | No intervention | –Patients will not receive intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cases with no clinical follow up
- Patients who refuse to participate
- Patients with no ability to cooperate with treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical stimulation (Elastomers)The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals | Device | Elastomers, Elastomers+TENS |
| TENStranscutaneous electrical stimulation | Procedure or surgery | Elastomers+TENS, TENS |
Primary outcome
Salivary flux
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarcilia A Silva, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mechanical stimulation (Elastomers) and TENS in people with Mucositis, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flux (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.