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NCT Number: NCT04717765

Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

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.

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Key information

Conditions

Oral Mucositis Bisphosphonate-Associated Osteonecrosis of the Jaw Bone Diseases Head and Neck Cancer Head and Neck Neoplasms Hyposalivation Jaw Diseases Mouth Diseases Mouth Neoplasms Musculoskeletal Diseases Necrosis Neoplasms Neoplasms by Site Oral Cancer Osteonecroses, Bisphosphonate Osteonecrosis Osteonecrosis Due to Drugs, Jaw Osteoradionecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Salivary Gland Diseases Stomatitis Stomatognathic Diseases Wounds and Injuries Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico Universitário

Santiago de Compostela, LA Coruña, 15702, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preventive, LLL Phototherapy and topical Vit E

Device

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

Device

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

Device

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

Device

Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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).

Secondary outcomes

  1. Interference of oral mucositis with quality of life - QLQ-C30 test

    Time frame: 6 months

    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.

  2. Interference of osteonecrosis of the jaws with quality of life - QLQ-C30 test

    Time frame: 12 months

    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.

  3. Hyposalivation with global saliva test - Oral mucositis

    Time frame: 6 months

    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.

  4. Xerostomia with s will be estimated by measurement. Xerostomia, with Xerostomia inventory - Oral mucositis

    Time frame: 6 months

    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.

  5. Pain assessed by EVA - score 0 to 10 - all patients

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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