Changes in Sense of Taste of Patients Submitted to Hematopoietic Stem Cell Transplantation
Condition: Taste Disorders
MeSH terms: Taste Disorders
Study type: Interventional

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.
    

Intervention name(s): laser therapy
Intervention type(s): Other
Intervention description(s): laser irradiation on the taste papillae
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)
Primary purpose: Treatment