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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
Fernanda de Paula Eduardo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Taste Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 2, 2018
    Last Updated
    May 8, 2021
    Sponsor
    Fernanda de Paula Eduardo
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    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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