Back to resultsPhotobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
Primary Purpose
Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Preventive, LLL Phototherapy and topical Vit E
Curative, LLL Phototherapy and topical Vit E
Preventive, LLL Phototherapy and LPRF
Curative, LLL Phototherapy and LPRF
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Dentistry, Health Promotion, Clinical trial, Oral Mucositis, Radiotherapy, Chemotherapy, Lasertherapy, Phototherapy, Hyposalivation, ORN, MRONJ
Eligibility Criteria
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.
Sites / Locations
- Hospital Clinico Universitário
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Experimental
Active Comparator
No Intervention
Experimental
Active Comparator
No Intervention
Experimental
Active Comparator
No Intervention
Experimental
Active Comparator
No Intervention
Arm Label
Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy
Preventive in oral mucositis caused by chemo or radiotherapy - Vit E
Preventive in oral mucositis caused by chemo or radiotherapy - mouthwash
Curative in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy
Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E
Curative in oral mucositis caused by chemo or radiotherapy- mouthwash
Preventive osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + extraction
Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction
Preventive osteonecrosis resulting from chemo or radiotherapy - extraction only
Curative osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + sequestrectomy
Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy
Curative osteonecrosis resulting from chemo or radiotherapy - sequestrectomy only
Arm 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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).
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.
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).
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT04717765
First Posted
January 11, 2021
Last Updated
May 11, 2023
Sponsor
University of Santiago de Compostela
1. Study Identification
Unique Protocol Identification Number
NCT04717765
Brief Title
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate, Osteonecrosis Due to Drugs, Jaw, Hyposalivation, Head and Neck Cancer, Oral Cancer
Keywords
Dentistry, Health Promotion, Clinical trial, Oral Mucositis, Radiotherapy, Chemotherapy, Lasertherapy, Phototherapy, Hyposalivation, ORN, MRONJ
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy
Arm Type
Experimental
Arm 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.
Arm Title
Preventive in oral mucositis caused by chemo or radiotherapy - Vit E
Arm Type
Active Comparator
Arm 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.
Arm Title
Preventive in oral mucositis caused by chemo or radiotherapy - mouthwash
Arm Type
No Intervention
Arm 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.
Arm Title
Curative in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy
Arm Type
Experimental
Arm 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.
Arm Title
Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E
Arm Type
Active Comparator
Arm 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.
Arm Title
Curative in oral mucositis caused by chemo or radiotherapy- mouthwash
Arm Type
No Intervention
Arm 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.
Arm Title
Preventive osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + extraction
Arm Type
Experimental
Arm 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.
Arm Title
Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction
Arm Type
Active Comparator
Arm 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.
Arm Title
Preventive osteonecrosis resulting from chemo or radiotherapy - extraction only
Arm Type
No Intervention
Arm 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.
Arm Title
Curative osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + sequestrectomy
Arm Type
Experimental
Arm 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.
Arm Title
Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy
Arm Type
Active Comparator
Arm 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.
Arm Title
Curative osteonecrosis resulting from chemo or radiotherapy - sequestrectomy only
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Preventive, LLL Phototherapy and topical Vit E
Intervention Description
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Intervention Type
Device
Intervention Name(s)
Curative, LLL Phototherapy and topical Vit E
Intervention Description
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Intervention Type
Device
Intervention Name(s)
Preventive, LLL Phototherapy and LPRF
Intervention Description
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Intervention Type
Device
Intervention Name(s)
Curative, LLL Phototherapy and LPRF
Intervention Description
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Primary Outcome Measure Information:
Title
Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy
Description
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.
Time Frame
3 months
Title
Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy
Description
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.
Time Frame
6 months
Title
Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy
Description
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.
Time Frame
3 months
Title
Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy
Description
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.
Time Frame
6 months
Title
Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy
Description
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.
Time Frame
3 months
Title
Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy
Description
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).
Time Frame
6 months
Title
Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy
Description
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.
Time Frame
3 months
Title
Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Interference of oral mucositis with quality of life - QLQ-C30 test
Description
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.
Time Frame
6 months
Title
Interference of osteonecrosis of the jaws with quality of life - QLQ-C30 test
Description
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.
Time Frame
12 months
Title
Hyposalivation with global saliva test - Oral mucositis
Description
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.
Time Frame
6 months
Title
Xerostomia with s will be estimated by measurement. Xerostomia, with Xerostomia inventory - Oral mucositis
Description
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.
Time Frame
6 months
Title
Pain assessed by EVA - score 0 to 10 - all patients
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clinico Universitário
City
Santiago De Compostela
State/Province
LA Coruña
ZIP/Postal Code
15702
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Learn more about this trial
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
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