- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242991
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manoela D Martins, PhD
- Phone Number: +555133085011
- Email: manomartins@gmail.com
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Recruiting
- Federal University of Rio Grande do Sul
-
Contact:
- Manoela D Martins, PhD
- Phone Number: +555133085011
- Email: manomartins@gmail.com
-
Sub-Investigator:
- Isadora P Klein, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intraoral photobiomodulation protocol
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).
|
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.
Other Names:
|
Active Comparator: Extraoral photobiomodulation protocol
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:
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
18 months
|
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).
|
18 months
|
Ulcerated oral mucositis
Time Frame: 18 months
|
Oral mucosal sites affected by ulcerated oral mucositis will be recorded.
|
18 months
|
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).
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18 months
|
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.
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18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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
- Study Chair: Manoela D Martins, PhD, Federal University of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBM and MO H&N
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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