An interventional study of Preventive photobiomodulation Therapy (PBMT) in Mucositis Oral, sponsored by Instituto Nacional de Cancer, Brazil. Recruiting at 1 site in Brazil. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Instituto Nacional de Cancer, Brazil · Not applicable, Interventional, and Prevention
This study aims to evaluate the photobiomodulation therapy (PBMT) for the prevention of oral mucositis in osteosarcoma patients submitted to high doses of methotrexate, through two different protocols. As a hypothesis, photobiomodulation for the prevention of oral mucositis after cycles of Cisplatin, Doxorubicin and Methotrexate is more effective than just the application of preventive low-power laser after Methotrexate alone.
This is a phase 3, randomized study, with patients diagnosed with osteosarcoma, enrolled at national cancer institute in Brazil (INCA), candidates for the Glato protocol (chemotherapy with doxorubicin, cisplatin, methotrexate and surgery). Patients will be randomly randomized in permuted blocks to groups 1 or 2. After confirming the eligibility criteria, patients will be invited to participate in the research before starting treatment and the TCLE/TALE will be applied in accordance with the Good Clinical Practice Guide and national ethical standards.
After signing the TALE/TCLE, patients will be instructed to perform oral hygiene after all meals, solid or liquid, with fluoridated toothpaste. On the first day of chemotherapy, in addition to the oral hygiene protocol, patients will be instructed to rinse their mouth twice a day with 0.12% chlorhexidine for 7 days. Once hyposalivation is diagnosed, patients will use oral humidifying gel four times a day (brand provided by the institution).
Photobiomodulation therapy
Oral assessment
Patients will be evaluated at the beginning of chemotherapy treatment (D1) and in a second moment between the third and seventh subsequent days (D3 to D7). In weeks 24 and 28, the dental evaluation will be carried out on D1 and between the second and seventh day (D2 to D7). In the weeks when the patient does not attend the hospital, a teleconsultation will be carried out to monitor the symptoms and, if a need for face-to-face evaluation is identified, an appointment will be scheduled.The mucous membranes will be evaluated for color, hydration, integrity, presence of oral mucositis and fungal, bacterial and viral infections.
The assessment of oral mucositis will be established according to the 1979 World Health Organization (WHO) classification and the criteria established by Sonis et al in 1999 (OMAS). The WHO assessment scale is made up of: Grade 0 - no change (Absent); Grade 1 - presence of erythema; Grade 2 - presence of erythema and ulcers, but the patient is able to ingest solids and liquids; Grade 3 - presence of ulcers, but the patient can only ingest a liquid and pasty diet and Grade 4 - presence of ulcers and impossibility of ingesting solids or liquids.
The OMAS scale considers the presence and size of ulcerations/pseudomembranes and erythema. Ulcerations/pseudomembranes will be evaluated according to the following scores: 0 - in the absence of lesions, 1 - in lesions smaller than 1 cm3, 2 - in lesions measuring between 1 and 3 cm3 and 3 - in lesions larger than 3cm3. Erythema will be evaluated according to the following scores: 0 - when absent, 1 - when present but not severe and 2 - when present and severe. A daily calculation will be made of the sum of the weighted average of the ulcerated area and intensity of the erythema (MP=2.5 x [(∑ui : 3 x Nu )+ (∑ei: 2 x Ne) ], where ∑ ui= sum of ulcerated area, Nu= number of ulcerated areas, ∑ei= sum of erythema intensity and Ne= number of areas with erythema A millimeter dental ruler will be used to measure the area.
Patients will be asked about the presence or absence of oral and oropharyngeal pain. Both will be classified according to CTCAE v5.0 into grades 1, 2 and 3, associated with the Visual Analogue Scale, where the value 0 corresponds to no pain and 10, the greatest pain. According to the standards established by the visual analogue scale, values from 0 to 3 correspond to mild pain, from 4 to 6 to moderate pain and from 7 to 10 to severe pain.
The collection of adverse events will only be directed to events of interest to the study, related to toxicities in the oral cavity. It is not expected that there will be collection and analysis of serious adverse events in this study.
Xerostomia will be assessed according to the presence or absence of complaints about this condition on the part of the patient, associated with sialometry according to CTCAE v5.0 in grades 1, 2 and 3, on the first day of each chemotherapy cycle and between the third and seventh day (D3 and D7) of the same week of chemotherapy. In weeks 24 and 28, salivary flow will be assessed on the first day (D1) and between the second and seventh day (D2 to D7).
Unstimulated saliva collection will be performed according to the method described by Davies et al. (2002) The patient will remain seated vertically in a comfortable place. The first saliva sample will be discarded and the rest will be collected in a decontaminated bottle. The collected saliva will be converted into ml/minute and an unstimulated salivary flow of less than 0.1mL/min will be considered hyposalivation. Clinical criteria will also be used to identify xerostomia, such as sublingual salivary lake, salivary thickening and adherence of the wooden spatula to the oral mucosa, associated with the patient's complaint.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 53 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Instituto Nacional de Cancer, Brazil is the lead sponsor of 41 studies on the registry; 7 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The application of preventive photobiomodulation therapy (PBMT) will be carried out on the day of methotrexate infusion (D1) and until the patient reaches a serum concentration equal to or less than 0.3 mmol/L.
Other: Preventive photobiomodulation Therapy (PBMT)
The application of preventive photobiomodulation therapy will be performed on the days of doxorubicin infusion and cisplatin and on the day after the doxorubicin infusion; on the day of the methotrexate infusion and until the patient reaches a serum concentration equal to or less than 0.3 mmol /L.
Other: Preventive photobiomodulation Therapy (PBMT)
The application of preventive TLBP will be performed with a laser device containing an aluminum phosphide and indium gallium diode (InGaAlP) emitting radiation in the red region of the electromagnetic spectrum (660 nm) with a power of 100mW and a beam area of 0.03 cm2 . An energy of 1J/point and an energy density of 33.3 J/cm2/point were determined, which will be applied punctually, with a distance between the points of 1cm, for 10s per point, totaling 9 points per region.
Also known as: Preventive Low Power Laser Therapy (TLBP )
Evaluate the best photobiomodulation protocol for preventing oral mucositis
To compare the effectiveness of two photobiomodulation protocols for the prevention of oral mucositis in patients with osteosarcoma undergoing high doses of methotrexate.
Time frame: Throughout the entire glato protocol.
Incidence of Oral Mucositis
Compare the duration of oral mucositis in patients undergoing preventive photobiomodulation in groups 1 (only in the chemotherapy cycle of methotrexate) and group 2 (in cycles of methotrexate, doxorubicin and cisplatin).
Time frame: From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.
Oral mucositis development time
Evaluate the development time of oral mucositis following the chemotherapy cycle.
Time frame: From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.
Assess salivary flow
Assess salivary flow before starting the first cycle of chemotherapy and in subsequent consultations.
Time frame: From the first day of infusion of each chemotherapy agent to the third and seventh day of the same week of infusion throughout the entire glato protocol.
Methotrexate serum levels
Assess serum methotrexate levels after chemotherapy infusion, until they are regularized, during the study.
Time frame: From the first day of meotrexate infusion until serum regularization.
Hospital internment
To evaluate the frequency of hospital admissions due to adverse events of interest to the study during chemotherapy treatment.
Time frame: Throughout the entire glato protocol.
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Jun 2025, 32 months after the start.
Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 32 months is above that.
Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.
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Instituto Nacional de Cancer, Brazil