Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
Primary Purpose
Taste Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Taste Disorders
Eligibility Criteria
Inclusion Criteria:
- submitted a bone marrow transplantation
- adequate oral hygiene
- absence of periodontal disease and other infectious foci prior to transplantation
- normal chewing, swallowing and phonation functions prior to transplantation
- participation of all previously planned laser therapy sessions.
Exclusion Criteria:
- not performing all the steps of oral hygiene oriented during the transplant
- lack of collaboration in diagnostic test of the palate
- lack of records on dietary intake
- absence of record of clinical data of interest for the project in the medical record
- death during the transplant or 30 days after the completion of the bone marrow transplantation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Placebo Group
Test Group
Arm Description
submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae
submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective.
Outcomes
Primary Outcome Measures
descriptive function of taste
using samples with the four basic flavors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03498950
Brief Title
Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
Official Title
Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fernanda de Paula Eduardo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
During conditioning with chemotherapy and radiotherapy for the transplantation of hematopoietic stem cells (HSCT), oral changes, such as mucositis, xerostomia infections and dysgeusia may occur. Low level laser therapy is used to minimize the intensity of the lesions, prevent ulcerations in the mucosa, and diminish the time of healing. To verify the efficacy of low level laser therapy in the prevention of dysgeusia in patients undergoing allogenic HSCT and detect the frequency of dysgeusia, the flavors most changed, and the association of these changes with the clinical conditions of the patient. The study sample will be composed of 80 patients selected at the Hematopoietic Stem Cell Transplantation Center of the "Hospital Israelita Albert Einstein". The patients will be randomized and distributed into two groups: Placebo Group (n=40) - submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae; Test Group (n= 40) - submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective. Daily intraoral exam will be performed in all the patients to evaluate mucositis, xerostomia and depapillation. The taste acuity test will determine the function of taste, using samples with the four basic flavors. This will be performed on the first day of conditioning (T0), during the stage of neutropenia (T1), at the time of discharge after transplantation (T2) and 100 days after transplantation (T3). A questionnaire will also be applied to evaluate the impact of changes in taste, smell and xerostomia on the quality of life. Our hypothesis is that the laser irradiation on the lingual papillae would help to prevent the changes in the cells of the taste papillae, preserving their morphology and function, which may attenuate the change in sense of taste and have a positive impact on the quality of life of patients during transplantation.
Detailed Description
uring conditioning with chemotherapy and radiotherapy for the transplantation of hematopoietic stem cells (HSCT), oral changes, such as mucositis, xerostomia infections and dysgeusia may occur. Low level laser therapy is used to minimize the intensity of the lesions, prevent ulcerations in the mucosa, and diminish the time of healing. To verify the efficacy of low level laser therapy in the prevention of dysgeusia in patients undergoing allogenic HSCT and detect the frequency of dysgeusia, the flavors most changed, and the association of these changes with the clinical conditions of the patient. The study sample will be composed of 80 patients selected at the Hematopoietic Stem Cell Transplantation Center of the "Hospital Israelita Albert Einstein". The patients will be randomized and distributed into two groups: Placebo Group (n=40) - submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae; Test Group (n= 40) - submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective. Daily intraoral exam will be performed in all the patients to evaluate mucositis, xerostomia and depapillation. The taste acuity test will determine the function of taste, using samples with the four basic flavors. This will be performed on the first day of conditioning (T0), during the stage of neutropenia (T1), at the time of discharge after transplantation (T2) and 100 days after transplantation (T3). A questionnaire will also be applied to evaluate the impact of changes in taste, smell and xerostomia on the quality of life. Our hypothesis is that the laser irradiation on the lingual papillae would help to prevent the changes in the cells of the taste papillae, preserving their morphology and function, which may attenuate the change in sense of taste and have a positive impact on the quality of life of patients during transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Taste Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study sample will be composed of 80 patients selected at the Hematopoietic Stem Cell Transplantation Center of the "Hospital Israelita Albert Einstein". The patients will be randomized and distributed into two groups.
Masking
Participant
Masking Description
The patients will be randomized and distributed into two groups: Placebo Group (n=40) - submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae; Test Group (n= 40) - submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae
Arm Title
Test Group
Arm Type
Experimental
Arm Description
submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective.
Intervention Type
Other
Intervention Name(s)
laser therapy
Intervention Description
laser irradiation on the taste papillae
Primary Outcome Measure Information:
Title
descriptive function of taste
Description
using samples with the four basic flavors
Time Frame
100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
submitted a bone marrow transplantation
adequate oral hygiene
absence of periodontal disease and other infectious foci prior to transplantation
normal chewing, swallowing and phonation functions prior to transplantation
participation of all previously planned laser therapy sessions.
Exclusion Criteria:
not performing all the steps of oral hygiene oriented during the transplant
lack of collaboration in diagnostic test of the palate
lack of records on dietary intake
absence of record of clinical data of interest for the project in the medical record
death during the transplant or 30 days after the completion of the bone marrow transplantation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda de P Eduardo
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20036797
Citation
Epstein JB, Barasch A. Taste disorders in cancer patients: pathogenesis, and approach to assessment and management. Oral Oncol. 2010 Feb;46(2):77-81. doi: 10.1016/j.oraloncology.2009.11.008. Epub 2009 Dec 28.
Results Reference
background
PubMed Identifier
19767788
Citation
Boer CC, Correa ME, Miranda EC, de Souza CA. Taste disorders and oral evaluation in patients undergoing allogeneic hematopoietic SCT. Bone Marrow Transplant. 2010 Apr;45(4):705-11. doi: 10.1038/bmt.2009.237. Epub 2009 Sep 21.
Results Reference
background
PubMed Identifier
16369163
Citation
Just T, Pau HW, Bombor I, Guthoff RF, Fietkau R, Hummel T. Confocal microscopy of the peripheral gustatory system: comparison between healthy subjects and patients suffering from taste disorders during radiochemotherapy. Laryngoscope. 2005 Dec;115(12):2178-82. doi: 10.1097/01.MLG.0000181502.07160.86.
Results Reference
background
PubMed Identifier
17393191
Citation
Schubert MM, Eduardo FP, Guthrie KA, Franquin JC, Bensadoun RJ, Migliorati CA, Lloid CM, Eduardo CP, Walter NF, Marques MM, Hamdi M. A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Support Care Cancer. 2007 Oct;15(10):1145-54. doi: 10.1007/s00520-007-0238-7. Epub 2007 Mar 29.
Results Reference
background
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Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
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