Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 579 for:    Taste Disorders

Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498950
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Fernanda de Paula Eduardo, Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment Phase
Taste Disorders Other: laser therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Placebo Group
submitted to the routine laser therapy protocol in addition to simulated laser irradiation on the taste papillae
Experimental: Test Group
submitted to the same laser therapy protocol as that of the Placebo Group, however, laser irradiation on the taste papillae will be effective.
Other: laser therapy
laser irradiation on the taste papillae




Primary Outcome Measures :
  1. descriptive function of taste [ Time Frame: 100 days ]
    using samples with the four basic flavors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications:
Layout table for additonal information
Responsible Party: Fernanda de Paula Eduardo, Dentist, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03498950     History of Changes
Other Study ID Numbers: 2591-16
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms