Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

Head and Neck Cancer Clinical Trial

Official title:

Photobiomodulation With Low Level Laser in the Prevention and Treatment of Oral Lesions (Mucositis, Hyposalivation and Osteonecrosis) Resulting From Anti-neoplastic Treatment With Chemotherapy or Radiotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717765
• Other study ID #: RCT-LB-VE-20
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: There are several manifestations in the oral mucosa resulting from antineoplastic treatments by chemo (QT) or radiotherapy (RT). In this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene.

MO and hyposalivation, which are related to damage to the salivary glands, are the most common manifestations, and ONJ is the most difficult to treat. The dentist can play an important role in prevention and treatment these oral lesions, directly influencing the patient's quality of life and adherence to antineoplastic treatment.

Objectives: The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment.

Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 2 experimental arms and a control group, carried out in a single center. Group 1, intervention with LLL phototherapy, Group 2, intervention with application of topical Vit E and Group 3, mouthwash with 0.12% chlorhexidine (usual clinical information). 360 patients will participate in this study from the Units of Oncology Medicine, Radiotetaphic Medicine and Oral Medicine, Oral Surgery and Implantology at the University of Santiago de Compostela. The segment of the patients will be given, an initial visit and returns every day that hears the application of antineoplastic treatment for the group of LLL phototherapy, returns of 15 days, one month, three months, six months, nine months and one year. In these return visits, evaluations and questionnaires will be carried out regarding all the variables that we will collect.

Predictable results: If the application of laser phototherapy or topical Vit E contributes to the cessation, reduction or improvement of the clinical evolution of the manifestation of oral lesions, these treatments could be immediately implemented in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with head and neck or breast cancer who will undergo chemotherapy or radiotherapy.

Exclusion Criteria:

• Participants who do not sign the informed consent.

• Patients who have been or will be treated by chemo and radiotherapy together.

• Patients in treatment of a cancer recurrence.

• Patients reporting diabetes or sjogren's syndrome.

Related Conditions & MeSH terms

• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Head and Neck Cancer
• Hyposalivation
• Mouth Neoplasms
• Mucositis
• Oral Cancer
• Oral Mucositis
• Osteonecroses, Bisphosphonate
• Osteonecrosis
• Osteonecrosis Due to Drugs, Jaw
• Osteoradionecrosis
• Stomatitis
• Xerostomia

Intervention

Device:
• Preventive, LLL Phototherapy and topical Vit E
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
• Curative, LLL Phototherapy and topical Vit E
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
• Preventive, LLL Phototherapy and LPRF
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
• Curative, LLL Phototherapy and LPRF
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitário	Santiago De Compostela	LA Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy	The main objective is to evaluate whether LLL phototherapy acts on preventing oral mucositis in patients who will receive chemotherapy. The result will be determined by the percentage of patients who reduce the intensity of the manifestation and/or do not develop oral mucositis, for this we will use the NCI-CTC mucositis scale of the "National Cancer Institute". Grade refers to the severity. Grades 1 through 5 (the most severe).; Will be compared to those who receive topical Vit. E or chlorhexidine mouthwash, in the prevention arms of the study.	3 months
Primary	Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy	The main objective is to assess whether LLL phototherapy works to prevent bone necrosis of the jaws in patients who need dental extractions and who will still receive chemotherapy. The result will be determined by the percentage of patients who do not develop bone necrosis after extraction and phototherapy, the " Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO/ASCO) Clinical Practice Guideline on Medication-Related Osteonecrosis of the Jaw" will be used for classification of bone necroses. Stage refers to the severity. Stages 1 through 3 (the most severe).; It will be compared with those who receive LPRF after extraction or only extraction, in the prevention arms of the study.	6 months
Primary	Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy	The main objective is to evaluate the efficacy of LLL phototherapy in the LLL phototherapy treating. The result will be determined by percentage of patients who develop oral mucositis after the first 10 days of treatment with chemotherapy, and who receive phototherapy, and have rapid regression of oral mucositis, for this we will use the NCI-CTC mucositis scale of the "National Cancer Institute". Grade refers to the severity. Grades 1 through 5 (the most severe).; Will be compared with patients receiving topical Vit. E or chlorhexidine mouthwash.	3 months
Primary	Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy	The main objective is to evaluate the efficacy of LLL phototherapy in the treatment of osteonecrosis of the jaws in patients with bone necrosis after receiving chemotherapy. The result will be determined by the percentage of patients who are cured of osteonecrosis after sequestromia and phototherapy, for this which we will use the " Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO/ASCO) Clinical Practice Guideline on Medication-Related Osteonecrosis of the Jaw" will be used for classification of bone necroses. Stage refers to the severity. Stages 1 through 3 (the most severe).; It will be compared to those who receive sequestromia and LPRF or just sequestromia.	6 months
Primary	Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy	The main objective is to evaluate whether LLL phototherapy acts on preventing oral mucositis in patients who will receive radiotherapy. The result will be determined by the percentage of patients who reduce the intensity of the manifestation and/or do not develop oral mucositis, for this we will use the NCI-CTC mucositis scale of the "National Cancer Institute". Grade refers to the severity. Grades 1 through 5 (the most severe).; Will be compared with patients receiving topical Vit. E or chlorhexidine mouthwash.	3 months
Primary	Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy	The main objective is to assess whether LLL phototherapy works to prevent bone necrosis of the jaws in patients who need dental extractions and who will still receive radiotherapy. The result will be determined by the percentage of patients who do not develop bone necrosis after extraction and phototherapy, the Notani scale, will be used for classification of bone necroses. Grade refers to the severity. Grades 1 through 3 (the most severe).	6 months
Primary	Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy	The main objective is to evaluate the efficacy of LLL phototherapy in the LLL phototherapy treating. The result will be determined by percentage of patients who develop oral mucositis after the first 10 days of treatment with radiotherapy, and who receive phototherapy, and have rapid regression of oral mucositis, for this we will use the NCI-CTC mucositis scale of the "National Cancer Institute". Grade refers to the severity. Grades 1 through 5 (the most severe).; Will be compared with patients receiving topical Vit. E or chlorhexidine mouthwash.	3 months
Primary	Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy	The main objective is to evaluate the efficacy of LLL phototherapy in the treatment of osteonecrosis of the jaws in patients with bone necrosis after receiving radiotherapy. The result will be determined by the percentage of patients who are cured of osteonecrosis after sequestromia and phototherapy, for which we will use the Notoni Scale. Grade refers to the severity. Grades 1 through 3 (the most severe).	6 months
Secondary	Interference of oral mucositis with quality of life - QLQ-C30 test	The quality of life of all patients in the mucositis study, whether chemotherapy or radiotherapy, preventive or curative, will be estimated using the EORTC core Quality of Life questionnaire QLQ-C30.	6 months
Secondary	Interference of osteonecrosis of the jaws with quality of life - QLQ-C30 test	The quality of life of all patients in the mucositis study, whether chemotherapy or radiotherapy, preventive or curative, will be estimated using the EORTC core Quality of Life questionnaire QLQ-C30.	12 months
Secondary	Hyposalivation with global saliva test - Oral mucositis	Alteration of salivary glands will be estimated by measurement; hyposalivation, by global saliva test, stimulated and unstimulated saliva, (GST l and ll).; Rates of less than 0.1-0.2ml/min for resting saliva and less than 0.5-0.7ml/min for stimulated saliva are considered abnormal.	6 months
Secondary	Xerostomia with s will be estimated by measurement. Xerostomia, with Xerostomia inventory - Oral mucositis	Alteration of salivary glands will be estimated by measurement. Xerostomia, by "Xerostomia inventory" a questionnaire containing 11 questions, with the intention of measure a subjective sensation of the patient.	6 months
Secondary	Pain assessed by EVA - score 0 to 10 - all patients	Pain will also be measured in all groups of the study, through the visual analogue - EVA Scale, adapted for pain.; Subjective evaluation of pain, indicated by the patient. Scale from 0 to 10 (the most intense).	6 months