Trial Title:
Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT
NCT ID:
NCT05759975
Condition:
Oral Mucositis
Hematopoietic Neoplasm
Xerostomia
Hyposalivation
Conditions: Official terms:
Hematologic Neoplasms
Mucositis
Stomatitis
Xerostomia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized to one of two groups for the duration of the study. Group I
(PBMI, n=21) photobiomodulation intraoral with a low potency laser, and Group II:
photobiomodulation with high power extraoral unfocused laser with 1 W power (PBME, n=21).
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
The outcomes assessor will not know the laser protocol of each patient (single blind) .
Intervention:
Intervention type:
Device
Intervention name:
Photobiomodulation therapy (intraoral)
Description:
Intraoral photobiomodulation therapy (660nm, 100mW, 10 J/cm 2 , 3 s/point) for the
management of oral side effects related during hematopoietic stem cell transplantation
(HSCT). Mainly in the decrease of oral OM rates and OM severity, healing of OM ulcers and
pain relief. Second, evaluate quality of life,hyposalivation/xerostomia, functional
evaluation and dysfagia, in the arm. All results obtained in the group will be compared
with the other arm.
Arm group label:
Intraoral photobiomodulation (PBMI)
Intervention type:
Device
Intervention name:
Photobiomodulation therapy (extraoral)
Description:
Extraoral photobiomodulation therapy (810 + 980 nm, 1 W, 6.11 J/cm2 , 30 s/point) for the
management of oral side effects related during hematopoietic stem cell transplantation
(HSCT). Mainly in the decrease of oral OM rates and OM severity, healing of OM ulcers and
pain relief. Second, evaluate quality of life,hyposalivation/xerostomia, functional
evaluation and dysfagia, in the arm. All results obtained in the group will be compared
with the other arm.
Arm group label:
Extraoral photobiomodulation (PBME)
Summary:
Patients undergoing hematopoietic cell transplantation (HSCT) receive high doses of
chemotherapy with or without radiotherapy to eradicate the underlying disease, which
induces a series of adverse effects, including in the oral cavity. Among the most common
oral lesions is oral mucositis (OM), which has been associated with greater morbidity and
important biological and economic impact.Currently, photobiomodulation (PBM) with
intraoral application has been recommended for the prevention of OM, however, few studies
have evaluated the impact of its extraoral use.
Detailed description:
The main objective of this study is to evaluate the effectiveness of extraoral PBM using
unfocused high-power laser compared to intraoral PBM with low-power laser in the
management of OM, mouth pain, functional capacity, development and duration of
hyposalivation and xerostomia and quality of life. This is a multicenter, randomized,
single blind clinical trial to be conducted at the Hospital de Clínicas de Porto Alegre
(HCPA) and at the AC Camargo Cancer Center Hospital.
All patients who accept participate of the study will assign an informed consent form.
For data management, the REDcap® software will be used, where all forms referring to
patients evaluation will be incorporated. 42 patients will be selected who will undergo
HSCT regardless of the underlying disease. Subsequently, upon accepting participation in
the study, participants will undergo a sequential allocation using the R shiny summary
statistics ® software by the variables of gender, age, type of HSCT and type of
conditioning and will be allocated into 2 groups: Group I : intraoral photobiomodulation
(660nm, 100mW, 10 J/cm 2 , 3 s/point) (PBMI, n=21) and Group II: extraoral
photobiomodulation (810 + 980 nm,1 W,6.11 J/cm 2, 30 s/point) with high power extraoral
unfocused laser with 1 W power (PBME, n=21). In both arms, the patients will receive
photobiomodulation therapy from the the beginning of the conditioning until D + 5 after
HSCT procedure. If any patient presenting or developing lesion after D + 5, this patient
will receive the photobiomodulation protocol stipulated in your respective group util
occur the healing of the lesion.
The study will be carried out by a dental surgeon who will carry out the initial
assessment and reassessments (blinded to the groups) and another who will carry out the
application of the PBM. Patients will be evaluated daily from the beginning of the
conditioning until the bone marrow grafting or while there are oral lesions.
If they do not develop lesions, after bone marrow grafting, the patients will be
evaluated weekly until hospital discharge. After clinical exam, grade and OM severity
will be evaluated, after that, classified according WHO and NCI scale, pain assessment
(VAS and NRS-101) and functional assessment, until D + 5 after HSTC procedure. The
evaluation of xerostomia/hyposalivation (stimulated and non-stimulated salivary flow and
xerostomia inventory) and quality of life will be performed in three moments, at the
beginning of the conditioning, on the day of the HSCT and on the bone marrow marrow
grafting day.
Saliva samples will be collected with SWABS, to futures microbioma analysis. The
statistical analyzes will be carried out in the PASW 18.0 program, initially the
evaluation of the data distribution will be carried out from the application of the
Shapiro-Wilk and Kolmogorov-Smirnov tests.
If from the application of these tests, the data show normal distribution (p>0.05), the t
test will be used. If the distribution proves to be non-normal from the application of
the test (p<0.05), the Wilcoxon test will be used. The p-value will be set to 5%.
Logistic regression will be used in fitted models to estimate the probability of
occurrence of OM (dependent variable) in relation to clinical demographic variables
(independent variables).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged 18 and scheduled for autologous or allogeneic HSCT.
- Patients undergoing myeloablative conditioning regimen
Exclusion Criteria:
- Patients previously submitted to autologous or allogeneic HSCT
- Patients on a non-myeloablative conditioning regimen
- Patients on a reduced-intensity conditioning regimen
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Federal University of Rio Grande do Sul
Address:
City:
Porto Alegre
Zip:
90035-004
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Manoela D Martins, PhD
Phone:
+555133085011
Email:
manomartins@gmail.com
Investigator:
Last name:
Luan NS Kovalski, Msc
Email:
Sub-Investigator
Start date:
January 13, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Federal University of Rio Grande do Sul
Agency class:
Other
Collaborator:
Agency:
AC Camargo Cancer Center
Agency class:
Other
Source:
Federal University of Rio Grande do Sul
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759975
