Clinical trial NCT04717765: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy
timeFrame: 3 months
measure: Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy
timeFrame: 6 months
measure: Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Chemotherapy
timeFrame: 3 months
measure: Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using the MASCC scale - stage 1 to 3 - Chemotherapy
timeFrame: 6 months
measure: Prevention of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy
timeFrame: 3 months
measure: Prevention of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy
timeFrame: 6 months
measure: Treatment of oral mucositis with LLL phototherapy, evaluation using NCI-CTC mucositis scale of the "National Cancer Institute" - grade 1 to 5 - Radiotherapy
timeFrame: 3 months
measure: Treatment of osteonecrosis of the jaws with LLL phototherapy, evaluation using Notani scale - grade 1 to 3 - Radiotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Interference of oral mucositis with quality of life - QLQ-C30 test
timeFrame: 6 months
measure: Interference of osteonecrosis of the jaws with quality of life - QLQ-C30 test
timeFrame: 12 months
measure: Hyposalivation with global saliva test - Oral mucositis
timeFrame: 6 months
measure: Xerostomia with s will be estimated by measurement. Xerostomia, with Xerostomia inventory - Oral mucositis
timeFrame: 6 months
measure: Pain assessed by EVA - score 0 to 10 - all patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitário
state: LA Coruña
Study officials:
References: