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

NCT05759975 | Unknown DMC FDA Device

• 1 other identifier: PBM and MO HSCT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Hematopoietic Neoplasm; Xerostomia; Hyposalivation

Outcome Measures

Primary Outcomes (2)

• Oral Mucositis evaluation according WHO scale

  The measurement of mucositis will be performed daily from the beginning of the conditioning therapy until the bone marrow grafting or while there are oral lesions. Mucositis will be scored according to WHO criteria: grade 0 (none), grade I (oral soreness, erythema), grade II (oral erythema, ulcers, solid and liquid diet tolerated), grade III (oral ulcers, liquid diet only), and grade IV (oral diet impossible).

  16 months

• Oral Mucositis evaluation according NCI scale

  The measurement of mucositis will be performed daily from the beginning of the conditioning therapy until the bone marrow grafting or while there are oral lesions. The National Cancer Institute (NCI) scale (NCI - Common Terminology Criteria for Adverse Events) will be performed: grade I (mucosal erythema), grade II ( patchy ulcerations with pseudomembranes), grade III (confluent ulceration or pseudomembranes, bleeding with minor trauma), and grade IV (tissue necrosis, significant spontaneous bleeding)

  16 months

Secondary Outcomes (9)

• Pain evaluation (VAS)

  16 months

• Pain evaluation (NRS-101)

  16 months

• Functional evaluation

  16 months

• Dysfagia

  16 months

• Hyposalivation/xerostomia

  16 months

Study Arms (2)

Intraoral photobiomodulation (PBMI)

ACTIVE COMPARATOR

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)

Device: Photobiomodulation therapy (intraoral)

Extraoral photobiomodulation (PBME)

ACTIVE COMPARATOR

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).

Device: Photobiomodulation therapy (extraoral)

Interventions

Photobiomodulation therapy (intraoral) 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.

Intraoral photobiomodulation (PBMI)

Photobiomodulation therapy (extraoral) 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.

Extraoral photobiomodulation (PBME)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and scheduled for autologous or allogeneic HSCT.
• Patients undergoing myeloablative conditioning regimen

You may not qualify if:

• Patients previously submitted to autologous or allogeneic HSCT
• Patients on a non-myeloablative conditioning regimen
• Patients on a reduced-intensity conditioning regimen

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• AC Camargo Cancer Center: 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; Hematologic Neoplasms; Xerostomia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Manoela D Martins, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Fábio A Alves, PhD

  A.C. Camargo Cancer Center

  STUDY CHAIR

Central Study Contacts

Manoela D Martins, PhD

CONTACT

+555133085011; manomartins@gmail.com

Luan NS Kovalski, Msc

CONTACT

+5554984327156; luankovalski1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor 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: 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).

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: March 8, 2023
• Study Start: January 13, 2023
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

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 referenced by the researcher interested

Locations

BR (1)