Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients

NCT05242991 | Unknown DMC FDA Device

• 1 other identifier: PBM and MO H&N
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Head and neck cancer (HNC) are among the most frequent malignancies in the world. The main treatment modalities for HNC are surgical excision, radiotherapy (RT), and chemotherapy (CT). Severe oral sequelae such as oral mucositis (OM), dysgeusia, opportunistic infections, trismus, and xerostomia/hyposalivation can affect HNC patients due to oncological treatment with RT and QT. Photobiomodulation therapy (PBMT) with an intraoral low-power laser has been studied as an excellent tool in the management of OM and xerostomia and thus improves the tolerability of RT in the head and neck region. The aim of this multicenter, randomized, single-blind clinical trial is to compare the effects of two photobiomodulation protocols (intraoral application low-level laser and defocused extraoral application of high-power laser) in the management of oral mucositis (OM) and xerostomia in head and neck cancer patients undergoing radiotherapy (RT). It is expected defocused extraoral high-power photobiomodulation shows results as good as intraoral photobiomodulation on the management of oral mucositis.

Conditions

Mucositis; Xerostomia; Hyposalivation

Keywords

mucositis; xerostomia; photobiomodulation; head and neck cancer; taste disorders; trismus

Outcome Measures

Primary Outcomes (5)

• Oral mucositis

  The measurement of mucositis will be performed daily from the first day of the radiotherapy sessions until healing by a blinded observer. Mucositis will be scored according to World Health Organization 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 alimentation impossible).

  18 months

• Oral mucositis

  The measurement of mucositis will be performed daily from the first day of the radiotherapy sessions until healing by a blinded observer. Mucositis will be scored according to 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 ulcerations or pseudomembranes, bleeding with minor trauma), and grade IV (tissue necrosis, significant spontaneous bleeding).

  18 months

• Ulcerated oral mucositis

  Oral mucosal sites affected by ulcerated oral mucositis will be recorded.

  18 months

• Xerostomia

  A subjective evaluation will be performed daily by a classification proposed by Eisbrush et al., 2003: grade 0 (none), grade I (), grade II (oral erythema, ulcers, solid and liquid diet tolerated), grade III (oral ulcers, liquid diet only), and grade IV (oral alimentation impossible).

  18 months

• Hyposalivation

  An objective evaluation will be performed weekly by measurement and weighing of non-stimulated and stimulated salivary flow (ml/min) as proposed by Eisbrush et al., 2003.

  18 months

Study Arms (2)

Intraoral photobiomodulation protocol

ACTIVE COMPARATOR

Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Intraoral protocol will utilize a low-level laser device (MMOptics Ltda, Sao Carlos, Sao Paulo, Brazil) with wavelength 660nm, power 100 mW, spot 0.03 cm², dose 10 J/cm², and time 3 seconds. The irradiations will be punctual and in a contact form, with 1 cm between the points, perpendicular to the oral mucosa, avoiding the tumor site and will be performed: 6 points on the labial mucosa (3 in the upper and 3 in the lower), 2 points on the labial commissure (1 on the right and 1 on the left), 8 points on the jugal mucosa (4 on the right and 4 on the left), 8 points on the lateral border of the tongue (4 on the right and 4 on the left), 5 points on the ventral tongue (2 on the right, 2 on the left side and 1 point on the apex), 4 points on the oral floor (2 on the right and 2 on the left side).

Device: Photobiomodulation therapy

Extraoral photobiomodulation protocol

ACTIVE COMPARATOR

Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Extraoral protocol will utilize a defocused high-level laser device (Gemini® Diode Laser - UltraDent) with wavelength 810 + 980 nm, power 1 W, spot 4.91 cm², dose 6.11 J/cm², and time 30 seconds. The irradiations will be punctual and in a contact form, perpendicular to the skin, avoiding the tumor site and will be performed: * 5 points on the face (2 on both right and left cheeks, 2 points on both right and left parotid gland region and 1 on the lip); * 5 points on the neck area (1 point on the sublingual gland region, 2 points on the right and left submandibular spaces and 2 points on the neck nearby lymphatic chain).

Device: Photobiomodulation therapy

Interventions

Photobiomodulation therapy DEVICE

Light therapy for the management of oral side effects related to radiotherapy, mainly in the decrease of oral mucositis (OM) rates and OM severity, healing of OM ulcers and pain relief.

Also known as: Lasertherapy

Extraoral photobiomodulation protocol; Intraoral photobiomodulation protocol

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 with a diagnosis of cancer in the oral cavity and oropharynx any clinical stage based on TNM staging of head and neck cancer;
• Patients who received oral care prior to oncological treatment;
• Patients who will receive conformational radiotherapy (RT-C3D) or Intensity-modulated radiotherapy (IMRT) from 50 Gy to 70 Gy (primary radiation field) in daily doses of 1.8-2, 12 Gy divided five times per week (from Monday to Friday), totalizing 6 to 7 weeks of treatment. They may receive exclusive RT or with chemotherapy concomitant with cisplatin (100 mg/m2 every 21 days or 50 mg/m2 per week);
• Patients feeding orally or by parenteral nutrition;
• Patients who agree to participate in the study after reading, filling, and signing the Consent Form for Participation in Clinical Research.

You may not qualify if:

• Patients who develop head and neck radiodermatitis and for this reason interrupt the survey;
• Patients who do not appear in four or more PBMT or RT sessions.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• AC Camargo Cancer Center: collaborator
• Instituto do Cancer do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (1)

• Klein IP, Pinto MBR, So BB, de Farias Gabriel A, Mendonca NF, da Cruz Santos LB, Farias KM, Mores AL, Martins MAT, Silva ACPRE, Brandao TB, Santos-Silva AR, Alves FA, Martins MD. Intraoral vs. extraoral photobiomodulation therapy for oral mucositis in head and neck cancer patients: a multicenter, randomized, single-blind clinical trial. Support Care Cancer. 2025 Sep 10;33(10):842. doi: 10.1007/s00520-025-09877-w.

  PMID: 40928526 DERIVED

MeSH Terms

Conditions

Mucositis; Xerostomia; Head and Neck Neoplasms; Taste Disorders; Trismus

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Neoplasms by Site; Neoplasms; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Fábio A Alves, PhD

  A.C. Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

• Ana Carolina P Ribeiro e Silva, PhD

  Instituto de Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

• Manoela D Martins, PhD

  Federal University of Rio Grande do Sul

  STUDY CHAIR

Central Study Contacts

Manoela D Martins, PhD

CONTACT

+555133085011; manomartins@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.
• 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.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 16, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: October 1, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

BR (1)