Trial Title:
Comparison of Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Oncology Patients
NCT ID:
NCT05811195
Condition:
Oral Mucositis
Chemotherapeutic Toxicity
Childhood Cancer
Conditions: Official terms:
Mucositis
Stomatitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be allocated and randomized into 2 groups: Group I: PBMI (n=17)
photobiomodulation intra oral low potency laser and Group II: PBME (n=17)
photobiomodulation with high potency extraoral unfocoused laser with 1W.
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
The outcomes assesor will not know the laser protocol of each patient (single blind)
Intervention:
Intervention type:
Device
Intervention name:
Diode Semiconductor, Duo
Description:
Intraoral photobiomodulation therapy (660nm, 3s/point, 10J/cm²) for the management for
the oral mucositis in pediatric patients. Mainly in the decrease of oral mucositis rates
severity, healing of the ulcers of OM. The results obtained will be compared with the
other group.
Arm group label:
Intraoral photobiomodulation (PBMI)
Intervention type:
Device
Intervention name:
Gemini laser
Description:
Extraoral photobiomodulation therapy (810 + 980 nm, 20s/point, 4.07J/cm²) for the
management for the oral mucositis in pediatric patients. Mainly in the decrease of oral
mucositis rates severity, healing of the ulcers of OM. The results obtained will be
compared with the other group.
Arm group label:
Extraoral photobiomodulation (PBME)
Summary:
Childhood cancers represent less than 1% of the malignant diseases diagnosed worldwide.
Treatment modalities for childhood malignancies will differ depending on the diagnosis.
The main treatments may include chemotherapy (QT), radiation therapy (RT), and surgery.
The toxicity caused by QT and RT generates adverse effects in the mouth, among them oral
mucositis (MO). MO is damage that occurs to the oral mucosa and these lesions are
extremely painful, uncomfortable, and cause great morbidity for patients. The main
treatment of MO is intraoral photobiomodulation therapy (TBMI), this therapy has been
widely used, reducing the severity and pain of MO in patients. The use of extraoral
photobiomodulation therapy (TFBME) has been employed in some recent studies and has shown
efficacy for reducing and improving the severity of OM. The present study aims to compare
the effect of two protocols of photobiomodulation therapy (TFBM) using intraoral and
extraoral low power laser in the prevention and treatment of OM in pediatric oncology
patients receiving treatment with high dose metrotexate (MTX-HD) and its chemotherapy
combinations. Initially, 34 pediatric and adolescent oncology patients receiving
intravenous (IV) QT from risk protocols will be selected. Participants will be allocated
into 2 groups: Group I: TFBMI (n=17) and Group II: TFBME (n=17). The study will be
conducted by a dental surgeon who will perform the initial assessment and reassessments
(blinded to the groups) and another who will apply the TFBM. Patients will be evaluated
daily from day 1 (D1 - beginning of the chemotherapy cycle) until D10 or until healing of
the lesions. The evaluation will consist of oral mucosa examination for grading of OM,
pain assessment, quality of life, oral health, depressionand saliva evaluation of
patients to assess. The analyses will be performed in the PASW 18.0 program, initially
the evaluation of the data distribution will be performed by applying the Shapiro-Wilk
and Kolmogorov-Smirnov tests. If, after applying these tests, the data show a normal
distribution (p>0.05), the t-test will be used. If the distribution is non-normal after
the application of the tests (p<0.05), the Wilcoxon test will be used. The p value will
be set at 5%. Logistic regression will be used in adjusted models to estimate the
probability of occurrence of OM.
Detailed description:
The main to compare two TFBM protocols using low-power laser and extraoral high-power
laser in preventing OM in pediatric and adolescent oncology patients receiving treatment
with antineoplastic chemotherapeutic agents. To evaluate the effectiveness of TFBM using
extraoral low-power laser and high-power laser in the prevention and treatment of OM in
pediatric patients receiving treatment with MTX-HD chemotherapy and its combinations.
Evaluate the impact of OM on the quality of life, anxiety, depression and pain of these
patients. Evaluate the concentration of inflammatory and pro-inflammatory cytokines in
saliva using the enzyme-linked immunosorbent assay (ELISA) in individuals undergoing
chemotherapy who develop OM. Evaluate the role of NET and TSE in the saliva of patients
undergoing chemotherapy who develop OM.
This is a controlled, randomized and blind clinical trial to evaluate the efficacy of the
protocol using low-power and extraoral high-power TFBM in the prevention and treatment of
OM in pediatric and adolescent oncology patients undergoing different chemotherapy
protocols. The study will be conducted at the Hospital de Clínicas de Porto Alegre (HCPA)
and AC. Camargo Center in the Pediatric Oncology Sector. After clarification and
authorization of the responsible persons, they will have to sign the Informed Consent
Form and the able research participants will sign the Informed Consent Form. The project
will be registered in the Clinical Trials platform (https://clinicaltrials.gov/) and
conducted according to the Consort checklist (Consolidated Standards of Reporting
Trials). For data collection and management, the software REDcap® (Research Electronic
Data Capture - Vanderbilt University, Nashville - Tennessee) and Google Drive will be
used, where all forms regarding the evaluation of patients will be inserted.
A minimum of 34 pediatric and adolescent oncology patients diagnosed with malignancies,
receiving intravenous (IV) QT of the following risk protocols for OM or some protocol
that these chemotherapy drugs are included, will be included in this study, being:
MTX-HD, combination chemotherapy of MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD
and cyclophosphamide. Patients who will be invited to participate in this study will be
hospitalized for oncologic treatment and the informed consent form (ICF) and the informed
consent form (ICF) will be applied at the Pediatric Oncology Department (3rd east) of the
Hospital de Clínicas de Porto Alegre (HCPA). All patients included in this study will be
submitted to a pre-treatment bedside dental evaluation and, if necessary, oral adaptation
procedures (restorative, periodontal or tooth extraction needs) will be performed by the
Hospital Dentistry of HCPA, and guidance will be given regarding the use of alcohol-based
mouthwash, brushing with soft toothbrush and fluoride toothpaste, as well as guidance on
the TFBM protocol and possible oral complications resulting from the QT treatment. All
patients will be followed throughout the antineoplastic treatment, receiving
reinforcement in oral hygiene orientation and guidance regarding side effects such as OM.
Information on gender (male/female), race, age (in years), medical history, underlying
pathology and treatment modality (chemotherapy protocols used), pain medication used
(medication category, dose and time of use), nutritional data (whether they are eating
orally or using an esophageal tube) will be collected from the electronic medical
records. One chemotherapy cycle from each patient included in the study will be
evaluated.
in the study will be evaluated (MTX-HD, MTX-HD combined with cyclophosphamide and
doxorubicin, and MTX-HD and cyclophosphamide). These data will be noted on a specific
form for this study. If necessary, the evaluator will only have access to this form at
the end of the patient's treatment in order to maintain the blinding of the study.
atients will be randomly allocated into two groups: TFBMI (n = 17) and TFBME (n = 17).
The study will be conducted by a dental surgeon who will perform the initial evaluation
and reassessments (blinded to the experimental group) and another who will perform the
TFBMT. Participants will be instructed not to give any spontaneous information about the
treatment during the clinical evaluation, so that the treatment group to which they
belong will not be identified. Following acceptance of participation in the study, the
participants will go through a stratified randomization by chemotherapy protocol used in
the treatment of childhood cancer.Randomization will be performed on Sealed Envelope
software and participants will be allocated into 2 groups: Group I - TFBMI (n=17):
Participants will receive TFBM from the first day of QT infusion, 5 times a week, from D1
(considered the beginning of chemotherapy infusion) until D10 (considered the peak of OM)
in cases that the OM is maintained for longer the patients will be followed and treated
until complete healing of the lesions.
Intraoral application: A low-power laser (Diode Semiconductor, Duo, MMOptics Ltda, São
Carlos, SP, Brazil) with a wavelength of 660 nm (red) will be used, with an adaptation in
power, since the MMOptics device with 40mW is no longer manufactured. Four anatomical
areas will be irradiated perpendicularly in oral mucosa through several anatomical points
with a distance of 1 cm approximately between them in order to cover the largest area per
cm² in each region. Group II - TFBM with the extraoral high-power laser (n=17):
Participants will receive TFBM from the first day of QT infusion, 5 times a week, from D1
(considered the beginning of chemotherapy infusion) until D10 (considered the peak of OM)
in cases that the OM remains longer the patients will be followed and treated until
complete healing of the lesions.
A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC,
distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm, previously
standardized and calibrated for extraoral application by power meter (Coherent Inc, Santa
Clara, CA) will be used. The equipment will be programmed with 1 W of power. The
responsible researcher will execute the TFBM and he will not carry out any type of
evaluation.
The application of the questionnaires and clinical evaluation will be carried out by
another examiner who will not be aware of the group to which each patient is allocated.
During the QT period, all patients will be evaluated daily for the presence and grading
of OM and pain. Saliva samples will be collected from participants of all groups, in
three moments of clinical evaluation, for further analysis of inflammatory cytones, NET
and TSE.
Questionnaires about quality of life, childhood depression and perception of parents and
guardians on the quality of life of patients will be carried out.
Initially, the evaluation of 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 test will be used t. If the distribution
proves to be non-normal after applying the tests (p<0.05), the Wilcoxon test will be
used. The p-value will be set to 5%. Logistic regression will be used in adjusted models
to estimate the probability of occurrence of mucositis (dependent variable) in relation
to clinical and demographic variables (independent variables). Analyzes will be performed
using the PASW 18.0.3.11 program.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of malignant neoplasia (hematological or solid tumors);
- Responsible and participants agree to the study participation after reading and
signing the Informed Consent Form (ICF) and Informed Term of Consent (TALE) for
participation in Clinical Research;
- They performed the chemotherapy infusions hospitalized in the pediatric oncology
department of the 3rd east of HCPA;
- Received the following chemotherapy protocols: MTX-HD, combination chemotherapy of
MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD and cyclophosphamide.
Exclusion Criteria:
- Participants will be excluded who:
- Patients over the age of 18 years
- Patients who will undergo HSCT
Gender:
All
Minimum age:
1 Month
Maximum age:
18 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:
Amanda F Gabriel
Email:
Sub-Investigator
Start date:
March 10, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Federal University of Rio Grande do Sul
Agency class:
Other
Collaborator:
Agency:
Hospital A.C. Camargo
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/NCT05811195
