Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT

NCT ID: NCT05759975

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2024-06-30

Brief 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).

Conditions

Oral Mucositis; Hematopoietic Neoplasm; Xerostomia; Hyposalivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intraoral photobiomodulation (PBMI)

The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present.

PBMI protocol will use the indium-gallium-aluminium-phosphorus diode laser (InGaAlP) (DUO® - MMOptics Ltda, São Carlos, Brazil). Four anatomical areas will be irradiated perpendicularly in the buccal mucosa through several anatomical points with a distance of approximately 1 cm between them, in order to cover the largest area per cm² by region.

Application points:

• Buccal mucosa: 9 points each side: bite line on cheeks and upper and lower internal buccal vestibule (18 points).
• Tongue: 4 points on each side, on the lateral and ventral edge (8 points).
• Floor of the mouth: 1 point on each side (2 points)
• Upper and lower lips: upper and lower lips (lip redness), bottom of upper and lower sulcus and buccal commissure, right and left sides (4 points).
• Soft palate: right and left side (2 points)

Group Type: ACTIVE_COMPARATOR

Photobiomodulation therapy (intraoral)

Intervention Type: DEVICE

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.

Extraoral photobiomodulation (PBME)

The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present.

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 the measurement of potency (Coherent Inc, Santa Clara, CA). The equipment will be programmed with 1 W of power. The application points will be carried out perpendicularly on the face.

Application points:

• 4 points on each cheek (2 on the right and 2 on the left)
• 1 on lips; patients with sealed lips being possible to cover the upper and lower lip
• 5 points in the cervical region (2 in the right submandibular space and 2 in the left submandibular space and submental space in the midline).

Group Type: ACTIVE_COMPARATOR

Photobiomodulation therapy (extraoral)

Intervention Type: DEVICE

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.

Interventions

Photobiomodulation therapy (intraoral)

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.

Intervention Type: DEVICE

Photobiomodulation therapy (extraoral)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AC Camargo Cancer Center

OTHER

Sponsor Role: collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Manoela Domingues Martins

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manoela D Martins, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Fábio A Alves, PhD

Role: STUDY_CHAIR

A.C. Camargo Cancer Center

Locations

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Manoela D Martins, PhD

Role: CONTACT

manomartins@gmail.com

+555133085011

Luan NS Kovalski, Msc

Role: CONTACT

luankovalski1@gmail.com

+5554984327156

Facility Contacts

Manoela D Martins, PhD

Role: primary

manomartins@gmail.com

+555133085011

Other Identifiers

PBM and MO HSCT

Identifier Type: -

Identifier Source: org_study_id