Oral MucositisNCT04717765
Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention
A study testing Preventive, LLL Phototherapy and topical Vit E, Curative, LLL Phototherapy and topical Vit E and Preventive, LLL Phototherapy and LPRF in people with Oral Mucositis and Osteoradionecrosis, run by University of Santiago de Compostela at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate
- What is being tested?
- Preventive, LLL Phototherapy and topical Vit E, Curative, LLL Phototherapy and topical Vit E and Preventive, LLL Phototherapy and LPRF
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2021to 31 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with head and neck or breast cancer who will undergo chemotherapy or radiotherapy.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinico Universitário
Santiago de Compostela, LA Coruña, 15702
About this study
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.
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.
Read more
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.
- Conditions
- Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate, Osteonecrosis Due to Drugs, Jaw, Hyposalivation, Head and Neck Cancer
- Being tested
- Preventive, LLL Phototherapy and topical Vit E, Curative, LLL Phototherapy and topical Vit E, Preventive, LLL Phototherapy and LPRF, Curative, LLL Phototherapy and LPRF
- Keywords
- Dentistry, Health Promotion, Clinical trial, Oral Mucositis, Radiotherapy, Chemotherapy, Lasertherapy, Phototherapy, Hyposalivation, ORN, MRONJ
- Medical subject headings
- Stomatitis, Osteoradionecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw, Xerostomia, Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive, LLL Phototherapy and topical Vit EDevice
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 EDevice
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Preventive, LLL Phototherapy and LPRFDevice
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
Curative, LLL Phototherapy and LPRFDevice
Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy | Experimental | 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. Receives: Device: Preventive, LLL Phototherapy and topical Vit E |
| Preventive in oral mucositis caused by chemo or radiotherapy - Vit E | Active comparator | 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. Receives: Device: Preventive, LLL Phototherapy and topical Vit E |
| Preventive in oral mucositis caused by chemo or radiotherapy - mouthwash | No intervention | 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 | 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. Receives: Device: Curative, LLL Phototherapy and topical Vit E |
| Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E | Active comparator | 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. Receives: Device: Curative, LLL Phototherapy and topical Vit E |
| Curative in oral mucositis caused by chemo or radiotherapy- mouthwash | No intervention | 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 | 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. Receives: Device: Preventive, LLL Phototherapy and LPRF |
| Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction | Active comparator | 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. Receives: Device: Preventive, LLL Phototherapy and LPRF |
| Preventive osteonecrosis resulting from chemo or radiotherapy - extraction only | No intervention | 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 | 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. Receives: Device: Curative, LLL Phototherapy and LPRF |
| Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy | Active comparator | 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. Receives: Device: Curative, LLL Phototherapy and LPRF |
| Curative osteonecrosis resulting from chemo or radiotherapy - sequestrectomy only | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 3 months
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).
Measured: 6 months
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.
Measured: 3 months
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).
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start10 Feb 2021
- Primary completion28 Feb 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717765
- Sponsor's protocol ID
- RCT-LB-VE-20
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04717765
- Acronym / sponsor ID
- RCT-LB-VE-20
- Conditions
- Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate, Osteonecrosis Due to Drugs, Jaw, Hyposalivation, Head and Neck Cancer
- Keywords
- Dentistry, Health Promotion, Clinical trial, Oral Mucositis, Radiotherapy, Chemotherapy, Lasertherapy, Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 22 Jan 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy | Experimental | Device: Preventive, LLL Phototherapy and topical Vit EApplication 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. |
| Preventive in oral mucositis caused by chemo or radiotherapy - Vit E | Active comparator | Device: Preventive, LLL Phototherapy and topical Vit ETopical 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. |
| Preventive in oral mucositis caused by chemo or radiotherapy - mouthwash | No intervention | –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 | Device: Curative, LLL Phototherapy and topical Vit EApplication 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. |
| Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E | Active comparator | Device: Curative, LLL Phototherapy and topical Vit ETopical 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. |
| Curative in oral mucositis caused by chemo or radiotherapy- mouthwash | No intervention | –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 | Device: Preventive, LLL Phototherapy and LPRFFor 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. |
| Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction | Active comparator | Device: Preventive, LLL Phototherapy and LPRFFor 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. |
| Preventive osteonecrosis resulting from chemo or radiotherapy - extraction only | No intervention | –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 | Device: Curative, LLL Phototherapy and LPRFPatients 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. |
| Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy | Active comparator | Device: Curative, LLL Phototherapy and LPRFPatients 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. |
| Curative osteonecrosis resulting from chemo or radiotherapy - sequestrectomy only | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with head and neck or breast cancer who will undergo chemotherapy or radiotherapy.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Preventive, LLL Phototherapy and topical Vit EInterventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy. | Device | Preventive in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy, Preventive in oral mucositis caused by chemo or radiotherapy - Vit E |
| Curative, LLL Phototherapy and topical Vit EInterventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy. | Device | Curative in oral mucositis caused by chemo or radiotherapy - LLL Phototherapy, Curative in oral mucositis caused by chemo or radiotherapy - mucositis Vit E |
| Preventive, LLL Phototherapy and LPRFInterventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy. | Device | Preventive osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + extraction, Preventive osteonecrosis resulting from chemo or radiotherapy - LPRF+ extraction |
| Curative, LLL Phototherapy and LPRFInterventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy. | Device | Curative osteonecrosis resulting from chemo or radiotherapy - LLL Phototherapy + sequestrectomy, Curative osteonecrosis resulting from chemo or radiotherapy - LPRF + sequestrectomy |
Primary outcome
Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 3 months
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
Time frame: 6 months
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).
5 secondary outcomes
Interference of oral mucositis with quality of life - QLQ-C30 test
Time frame: 6 months
Interference of osteonecrosis of the jaws with quality of life - QLQ-C30 test
Time frame: 12 months
Hyposalivation with global saliva test - Oral mucositis
Time frame: 6 months
Xerostomia with s will be estimated by measurement. Xerostomia, with Xerostomia inventory - Oral mucositis
Time frame: 6 months
Pain assessed by EVA - score 0 to 10 - all patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided. We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive, LLL Phototherapy and topical Vit E, Curative, LLL Phototherapy and topical Vit E and Preventive, LLL Phototherapy and LPRF in people with Oral Mucositis and Osteoradionecrosis, run by University of Santiago de Compostela at 1 site in Spain.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Nov 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.