MucositisNCT05242991
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
A study testing Photobiomodulation therapy in people with Mucositis and Xerostomia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mucositis, Xerostomia, Hyposalivation
- What is being tested?
- Photobiomodulation therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Manoela D Martins, PhD, +555133085011, manomartins@gmail.com
Isadora P Klein, MSc
About this study
Official title: Comparison of Two Photobiomodulation Protocols for the Oral Mucositis and Xerostomia Prevention in Irradiated Head and Neck Cancer Patients: a Randomized, Multicenter, Single-blind Controlled Clinical Trial
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.
Read the detailed description
Radiotherapy (RT) and chemotherapy-induced oral side effects, as oral mucositis, and xerostomia are extremely challenging for professionals in the supportive care for head and neck squamous cell carcinoma (HNSCC) patients. There is a substantial evidence about the benefits of photobiomodulation in the management of these oral side effects, mainly in the decrease of oral mucositis (OM) rates and OM severity, healing of OM ulcers and pain relief by intraoral low-level lasers. However, new parameters as extraoral applications by defocused high-power lasers have been investigated to improve the OM outcomes, the patients' complaints, and the experience in the clinical assistance by professionals. Thus, 132 H\&N cancer patients will be, globally and simultaneously, randomized according to clinical stage of head and neck cancer, type of treatment (isolated RT or RT and QT), type of RT (RTC3D or IMRT) and center involved (A.C. Camargo Cancer Center or State of São Paulo Cancer Institute or Porto Alegre Clinics Hospital). The randomized patients can be allocated into two groups: Group I: intraoral photobiomodulation with low level laser therapy (660nm, 100 mW, 10 J/cm2, 3 s/point) and Group II: extraoral photobiomodulation with high level laser therapy (810 + 980 nm, 1000 mW, 6.11 J/cm2, 30 s/point). PBMT will be performed daily, 5 times per week during the radiotherapy or until wound healing of OM lesions by a trained professional. Oral mucositis, pain, xerostomia, dysphagia, dysgeusia, oral functions, labial hydration and radiodermatitis will be evaluated daily. Salivary flow and trismus will be assessed weekly, and two questionaries (OHIP-14 and Vanderbilt) will be assessed on the first day of RT, on the middle of RT regimen, on the final of RT regimen and three months later RT sessions.
- Conditions
- Mucositis, Xerostomia, Hyposalivation
- Being tested
- Photobiomodulation therapy
- Keywords
- mucositis, xerostomia, photobiomodulation, head and neck cancer, taste disorders, trismus
- Medical subject headings
- Mucositis, Xerostomia, Head and Neck Neoplasms, Taste Disorders, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapyDevice
Also called Lasertherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Photobiomodulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 18 months
Ulcerated oral mucositis
Oral mucosal sites affected by ulcerated oral mucositis will be recorded.
Measured: 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).
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Mar 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of two groups for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- AC Camargo Cancer Center, Instituto do Cancer do Estado de São Paulo
- Responsible party
- Principal investigator, Manoela Domingues Martins, Federal University of Rio Grande do Sul
- Investigators
- Fábio A Alves, PhD, Principal investigator, A.C. Camargo Cancer CenterAna Carolina P Ribeiro e Silva, PhD, Principal investigator, Instituto de Cancer do Estado de São PauloManoela D Martins, PhD, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242991
- Sponsor's protocol ID
- PBM and MO H&N
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40928526
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Photobiomodulation Protocols for the Oral Mucositis and Xerostomia Prevention in Irradiated Head and Neck Cancer Patients: a Randomized, Multicenter, Single-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05242991
- Acronym / sponsor ID
- PBM and MO H&N
- Conditions
- Mucositis, Xerostomia, Hyposalivation
- Keywords
- mucositis, xerostomia, photobiomodulation, head and neck cancer, taste disorders, trismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- AC Camargo Cancer Center, Instituto do Cancer do Estado de São Paulo
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiotherapy (RT) and chemotherapy-induced oral side effects, as oral mucositis, and xerostomia are extremely challenging for professionals in the supportive care for head and neck squamous cell carcinoma (HNSCC) patients. There is a substantial evidence about the benefits of photobiomodulation in the management of these oral side effects, mainly in the decrease of oral mucositis (OM) rates and OM severity, healing of OM ulcers and pain relief by intraoral low-level lasers. However, new parameters as extraoral applications by defocused high-power lasers have been investigated to improve the OM outcomes, the patients' complaints, and the experience in the clinical assistance by professionals. Thus, 132 H\&N cancer patients will be, globally and simultaneously, randomized according to clinical stage of head and neck cancer, type of treatment (isolated RT or RT and QT), type of RT (RTC3D or IMRT) and center involved (A.C. Camargo Cancer Center or State of São Paulo Cancer Institute or Porto Alegre Clinics Hospital). The randomized patients can be allocated into two groups: Group I: intraoral photobiomodulation with low level laser therapy (660nm, 100 mW, 10 J/cm2, 3 s/point) and Group II: extraoral photobiomodulation with high level laser therapy (810 + 980 nm, 1000 mW, 6.11 J/cm2, 30 s/point). PBMT will be performed daily, 5 times per week during the radiotherapy or until wound healing of OM lesions by a trained professional. Oral mucositis, pain, xerostomia, dysphagia, dysgeusia, oral functions, labial hydration and radiodermatitis will be evaluated daily. Salivary flow and trismus will be assessed weekly, and two questionaries (OHIP-14 and Vanderbilt) will be assessed on the first day of RT, on the middle of RT regimen, on the final of RT regimen and three months later RT sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two groups for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Intraoral photobiomodulation protocol | Active comparator | Device: Photobiomodulation therapyPatients 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). |
| Extraoral photobiomodulation protocol | Active comparator | Device: Photobiomodulation therapyPatients 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation therapyAlso: LasertherapyLight 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. | Device | Extraoral photobiomodulation protocol, Intraoral photobiomodulation protocol |
Primary outcome
Oral mucositis
Time frame: 18 months
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).
Oral mucositis
Time frame: 18 months
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).
Ulcerated oral mucositis
Time frame: 18 months
Oral mucosal sites affected by ulcerated oral mucositis will be recorded.
Xerostomia
Time frame: 18 months
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).
Hyposalivation
Time frame: 18 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 40928526Klein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fábio A Alves, PhD principal investigator
A.C. Camargo Cancer Center
Ana Carolina P Ribeiro e Silva, PhD principal investigator
Instituto de Cancer do Estado de São Paulo
Manoela D Martins, PhD study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy in people with Mucositis and Xerostomia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoela D Martins, PhD (+555133085011, manomartins@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.