Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

University of Santiago de Compostela

Status: Completed

Conditions: Osteoradionecrosis; Osteonecrosis Due to Drugs, Jaw; Osteonecroses, Bisphosphonate; Hyposalivation; Oral Mucositis; Oral Cancer; Head and Neck Cancer

Treatments: Device: Curative, LLL Phototherapy and LPRF; Device: Preventive, LLL Phototherapy and topical Vit E; Device: Preventive, LLL Phototherapy and LPRF; Device: Curative, LLL Phototherapy and topical Vit E

Study type: Interventional

Funder types: Other

Identifiers

NCT04717765

RCT-LB-VE-20

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 12 patient groups

Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy

Experimental group

Description:

Application of LLL phototherapy from the first day until the last day, on all days that the chemo or radiotherapy treatment is administered. If the patient still shows evidence of mucositis at the end of the treatment, additional applications can be performed. Application: in wavelength 660 nm (red), there will be 78 intra oral points, with a time of 10 seconds per point, at a power of 100 mw, totaling a power of 1J per point.

Treatment:

Device: Preventive, LLL Phototherapy and topical Vit E

Preventive in oral mucositis caused by chemo or radiotherapy - Vit E

Active Comparator group

Description:

Topical Vit. E spray, from the first day to the last day, every day that the chemo or radiotherapy treatment is administered. Application: on the first day the professional will demonstrate the application on intra-oral mucous points. On the other days the patient will do self application, twice a day.

Treatment:

Device: Preventive, LLL Phototherapy and topical Vit E

Preventive in oral mucositis caused by chemo or radiotherapy - mouthwash

No Intervention group

Description:

Oral hygiene control and mouthwash with chlorhexidine 0.12%, from the first to the last day of administration of the chemo or radiotherapy treatment. On the first day the professional will demonstrate the care. On the other days the care will be taken by the patient himself, for at least three times a day.

Curative in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy

Experimental group

Description:

Application of LLL phototherapy from the tenth day until the last day, on all days that the chemo or radiotherapy treatment is administered. If the patient still shows evidence of mucositis at the end of the treatment, additional applications can be performed. Application: in wavelength 660 nm (red), there will be 78 intra oral points, with a time of 10 seconds per point, at a power of 100 mw, totaling a power of 1J per point.

Treatment:

Device: Curative, LLL Phototherapy and topical Vit E

Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E

Active Comparator group

Description:

Topical Vit. E spray, application from the tenth day, and until the last day, every day that the chemo or radiotherapy treatment is administered. Application: on the first day the professional will demonstrate the application on intra-oral mucous points. On the other days the patient will do self application, twice a day.

Treatment:

Device: Curative, LLL Phototherapy and topical Vit E

Curative in oral mucositis caused by chemo or radiotherapy- mouthwash

No Intervention group

Description:

Oral hygiene control and mouthwash with chlorhexidine 0.12%, from the tenth to the last day of administration of the chemo or radiotherapy treatment. On the first day the professional will demonstrate the care. On the other days the care will be taken by the patient himself, for at least three times a day.

Preventive osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + extraction

Experimental group

Description:

For patients who need dental extraction for the adequacy of the oral cavity. Application of LLL phototherapy on the day the dental extraction is performed and every 72hr, totaling 5 applications. It must be done at least 3 months before the beginning of the chemo or radiotherapy treatment. Application: in wavelength 660 nm (red), alveolar ridge, 1 point per cm², with a time of 10 seconds per point, at a power of 100 mw, totaling a power of 1J per point. In wavelength 808 nm (infrared), buccal and lingual/palatal board 2 points in the length of the root, with a time of 20 seconds per point, at a power of 100 mw, totaling a power of 2J per point.

Treatment:

Device: Preventive, LLL Phototherapy and LPRF

Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction

Active Comparator group

Description:

For patients who need dental extraction for the adequacy of the oral cavity. LPRF placement on the day the tooth extraction is performed. The procedure must be performed at least 3 months before the start of chemo or radiotherapy treatment. After the LPRF has been placed, the suture should be done in a way that facilitates healing for primary intention.

Treatment:

Device: Preventive, LLL Phototherapy and LPRF

Preventive osteonecrosis resulting from chemo or radiotherapy - extraction only

No Intervention group

Description:

For patients who need dental extraction for the adequacy of the oral cavity, the procedure must be performed at least 3 months before the start of chemo or radiotherapy treatment. The suture should be done in a way that facilitates healing for primary intention.

Curative osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + sequestrectomy

Experimental group

Description:

Patients who have been diagnosed with bone necrosis after treatment with chemo or radiotherapy, clinical confirmation and radiography. Bone sequestrectomy, removal of necrotic tissue and application of LLL phototherapy on the day of surgery and every 72hr, totaling 5 applications. The suture should be done in a way to facilitate healing for primary intention. Application: in wavelength 660 nm (red), alveolar ridge, 1 point per cm², with a time of 10 seconds per point, at a power of 100 mw, totaling a power of 1J per point. In wavelength 808 nm (infrared), buccal and lingual/palatal board 2 points in the length of what would be the dental root, with a time of 20 seconds per point, at a power of 100 mw, totaling a power of 2J per point.

Treatment:

Device: Curative, LLL Phototherapy and LPRF

Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy

Active Comparator group

Description:

Patients who have been diagnosed with bone necrosis after treatment with chemo or radiotherapy, clinical confirmation and radiography. Bone sequestrectomy, removal of necrotic tissue and placement of the LPRF on the day of surgery will be performed. After the LPRF is placed, the suture should be done in a way that facilitates healing for primary intention.

Treatment:

Device: Curative, LLL Phototherapy and LPRF

Curative osteonecrosis resulting from chemo or radiotherapy - sequestrectomy only

No Intervention group

Description:

Patients who were diagnosed with bone necrosis after treatment with chemo or radiotherapy, clinical confirmation and radiography. Bone sequestrectomy and removal of necrotic tissue will be performed. The suture should be done in a way that facilitates healing for primary intention.