Comparison of Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Oncology Patients

NCT05811195 | Recruiting DMC FDA Device

• 1 other identifier: PBM and MO IN CHEMIOINDUCED
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Mucositis; Chemotherapeutic Toxicity; Childhood Cancer

Outcome Measures

Primary Outcomes (3)

• Oral mucositis evalution according World Health Organization (WHO) scale

  According to the classification criteria to World Health Organization (WHO, 1979): Grade 0 None Grade 1 Erythema, oral mucosal tenderness, pain Grade 2 Erythema, ulcerated lesion, can swallow solid food Grade 3 Ulcerated lesions require only liquid diet Grade 4 Impossible to eat, solid or liquid

  16 months

• Oral mucositis evalution according National Cancer Institute (NCI) scale

  According to the classification criteria to NCI 1999: Grade 0 None Grade 1 Painless ulcers, erythema or mild pain in the absence of lesions Grade 2 Painful erythema, edema or ulcers but can eat/swallow Grade 3 Painful erythema, edema or ulcers requiring IV hydration Grade 4 Severe ulcerations or requires parenteral/enteral nutrition support or prophylactic intubation

  16 months

• Oral mucositis Children's International Mucositis Evaluation Scale (CHIMES)

  Childhood Mucositis Evaluation (CHIMES). For the CHIMES- BR version items 1-4 are scored from 0 (best score) to 5 (worst score), the remaining items are answered with yes or no response and are assigned scores of 0 and 1, respectively. The maximum total score is 23.

  16 months

Secondary Outcomes (7)

• Pain evalution The Visual Analogic Scale (VAS)

  16 months

• Pain evolution - Wong Baker Faces

  16 months

• Quality of Life Assessment

  16 months

• Caregivers' Quality of Life Assessment

  16 months

• Anxiety and depression assessment

  16 months

Study Arms (2)

Intraoral photobiomodulation (PBMI)

ACTIVE COMPARATOR

Intraoral application: A low-power laser (Diode Semiconductor, Duo, MMOptics Ltda, São Carlos, SP, Brazil) with a wavelength of 660 nm (red). 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. Application points: * Jugal mucosa: 4 points for each side: upper and lower internal buccal vestibule, (8 points). * Jugal mucosa for younger children 2 points internal buccal vestibule in the center - each side (4 points) * Tongue: 2 points on right and left lateral border and 1 point on right and left belly (6 points) * Oral floor: (2 points). * Upper and lower lips: 2 points on upper inner labial mucosa, 2 points on lower inner labial mucosa (4 points). * Soft palate: right and left sides (2 points)

Device: Diode Semiconductor, Duo

Extraoral photobiomodulation (PBME)

ACTIVE COMPARATOR

A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm. The equipment will be programmed with 1 W of power. * 4 points - on each side of the face (2 on the right 2 on the left); * 2 points - on each side of the face: for younger children 1 point will be performed on each side of the face (1 on the right, 1 on the left) * 1 point on the lip; patients with sealed lips being able to cover both the upper and lower lip; * 5 points in the neck region (2 in right submandibular space and 2 in left submandibular space and submental space in the midline). * 3 points in the neck region for younger children (1 in right submandibular space and 1 in left submandibular space and submental space in the midline)

Device: Gemini laser

Interventions

Diode Semiconductor, Duo DEVICE

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.

Intraoral photobiomodulation (PBMI)

Gemini laser DEVICE

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.

Extraoral photobiomodulation (PBME)

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants will be excluded who:
• Patients over the age of 18 years
• Patients who will undergo HSCT

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital A.C. Camargo: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-004, Brazil

RECRUITING

MeSH Terms

Conditions

Stomatitis; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Manoela D Martins, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Fabio A Alves, PhD

  A.C Camargo Center

  STUDY CHAIR

Central Study Contacts

Manoela D Martins, PhD

CONTACT

555133085011; manomartins@gmail.com

Amanda F Gabriel

CONTACT

5551984916271; amanda_dfg@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assesor will not know the laser protocol of each patient (single blind)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 13, 2023
• Study Start: March 10, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the outcomes, for one year
• Access Criteria: If formally solicited and referencead by the researcher interestend

Locations

BR (1)