Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT

NCT06071637 | Recruiting Phase 3 DMC

• 1 other identifier: 67172223.9.0000.5274
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application of two wavelengths, red and infrared region in the mouth and neck) in the prevention of oral mucositis and oropharyngeal pain, dysphagia, TPN and opioid use in patients undergoing HSCT allogenic. Materials and methods: This is a phase III, double-blind, randomized study that will use LBP to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). Patients will be included enrolled at the Bone Marrow Transplant Center - Cancer Hospital I - INCA, with indication of allogeneic HSCT, over 18 years old, able to cooperate with the treatment and perform the oral hygiene protocol, who present oral mucosa complete on the first day of conditioning (D-7) and who agree to participate in the study through the term of free and clarified informed consent. The randomization will be carried out in permuted blocks using the REDCap® program by a member of the non-blind team. In group A, extraoral applications will be carried out with the issuance of radiation in the infrared region of the electromagnetic spectrum (808nm) and intraorally in the red region of the electromagnetic spectrum (660nm). In group B, the extra applications and intraoral will be performed with simultaneous double radiation emission in the regions red and infrared of the electromagnetic spectrum (660nm/808nm). for both groups will use the device from DMC (São Carlos, São Paulo, Brazil), with a indium gallium aluminum phosphide (InGaAlP) and aluminum gallium arsiade diode (AlGaAs), with a power of 100mW and a beam area of 0.09842 cm². The LBP will be performed by a dental surgeon, on weekdays, starting on D-7 and end on the day of the "marrow take" (patient presents 500 neutrophils for three days consecutive). The region treated in extraoral applications will be the carotid triangle bilateral, bounded by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior border of the sternocleidomastoid muscle; and intraorally, the mucous membranes right and left cheeks, lower and upper lips, upper and lower labial mucous membranes, right and left lateral borders of the tongue, lingual belly, buccal floor and soft palate. Patients will be evaluated daily (weekdays per week) for oral mucositis, pain in the oral cavity and oropharynx, dysphagia, use of total parenteral nutrition and opioids. Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know about the treatment that the patient will receive. The data from interest will be collected from the physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®. Statistical analyzes will be carried out using the latest available version of the R software for Windows. It will be A descriptive analysis of the data found in the clinical, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the chi-square test of Pearson. Statistical analyzes will be performed using the latest available version of the R software for Windows. A descriptive analysis of the data found will be carried out in clinical examination, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the Pearson's chi-square test. Mucositis-free survival analyzes (any degree) and dysphagia (any degree) will be performed by the Kaplan-Meier method and the curves compared by log-rank test. The time interval between the start of conditioning and date of first grade ≥1 mucositis or dysphagia to date of the "marrow take" (500 neutrophils in the peripheral blood for three consecutive days). Participants without mucositis or dysphagia will be censored on the date of marrow collection. Tests of hypothesis with p-value \< 0.05. The sample calculation predicted 82 patients, who will be evaluated by intention of treatment, counting with 10% loss to reach 37 patients in group A and 37 in group B. The estimate of the presence of oral mucositis grades 2, 3 and 4 in group A is 36.8% and in group B 10%. The estimate of the presence of dysphagia grades 3 and 4 (or pain in oropharynx grades 2 and 3) in group A is 80% and in group B 40%. the statistical test The two-tailed Z test with pooled variance was used, with a type 1 error of 0.05 and the error type 2 of 0.20. This research project was approved by the Research Ethics Committee responsible (CAAE 67172223.9.0000.5274, opinion No. 5.947.434) and will be conducted in a according to Resolution 466/12 of the National Health Council and the Good News Guide Clinical Practices.

Conditions

Hematopoietic Stem Cell Transplantation; Low-Level Light Therapy; Stomatitis

Keywords

Hematopoietic Stem Cell Transplantation; Low-Level Light Therapy; Stomatitis

Outcome Measures

Primary Outcomes (5)

• Prevention of oral mucositis according to WHO and OMAS scale

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Prevention of oropharyngeal pain according to the CTCAE v5.0 and the Visual Analog Scale

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Prevention of dysphagia according to the CTCAE v5.0 scale

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Prevention of the need for total parenteral nutrition

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Prevention of the need for opioid use

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

Secondary Outcomes (7)

• Association between the incidence of oral mucositis (any degree) and the prophylactic laser therapy protocol used

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Association between the incidence of pain in the oral cavity and oropharynx (any degree) and the prophylactic laser therapy protocol used

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Association between the incidence of dysphagia (any degree) and the prophylactic laser therapy protocol used

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Association between oral mucositis-free survival (any grade) and the prophylactic laser therapy protocol used

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

• Association between dysphagia-free survival (any degree) and the prophylactic laser therapy protocol used

  During the period of hospitalization due to HSCT, approximately 21 to 28 days

Study Arms (2)

Group A - single emission

ACTIVE COMPARATOR

The application will be carried out with the DMC device, with a power of 100mW, with a beam area of 0.09842 cm² in each optical fiber. Extraoral: A gallium and aluminum arsiade diode with emission of radiation in the infrared region of the electromagnetic spectrum (808 nm). An energy of 4J/point were determined, which will be applied punctually, with a distance between points of a maximum of 1cm, for 40s per point, totaling 9 points per region; Intraoral: An indium gallium aluminum phosphide diode with emission of radiation in the red region of the electromagnetic spectrum (660 nm). An energy of 1J/point were determined, which will be applied punctually, with a distance between points of a maximum of 1cm, for 10s per point, totaling 9 points per region .

Procedure: Double low-power laser therapy simultaneous applicated

Group B - double emission

EXPERIMENTAL

The application will be carried out with the DMC device, with a power of 100mW, with a beam area of 0.09842 cm² in each optical fiber. Extraoral: An indium gallium aluminum phosphide diode and gallium aluminum arsiade with double radiation emission simultaneously in the red and infrared region of the electromagnetic spectrum (660 nm/808nm). An energy of 4J/point were determined, which will be applied punctually, with a maximum distance between points of 1cm, for 20s per point, totaling 9 points per region; Intraoral: An indium gallium aluminum phosphide diode and gallium aluminum arsiade with double radiation emission simultaneously in the red and infrared region of the electromagnetic spectrum (660nm/808nm). An energy of 1J / point (0.5J in the red and 0.5 in the infrared) were determined, which will be applied punctually, with a distance between points of no maximum 1cm, for 5s per point, totaling 9 points per region.

Procedure: Double low-power laser therapy simultaneous applicated

Interventions

Double low-power laser therapy simultaneous applicated PROCEDURE

Double low-power laser therapy, with simultaneous application of two wavelengths, red and infrared in in the mouth and neck

Group A - single emission; Group B - double emission

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for allogeneic HSCT;
• Patients over 18 years old;
• Patients with intact oral mucosa on the first day of conditioning (D-7);
• Patients able to cooperate with treatment;
• Patients capable of performing the oral hygiene protocol;
• Patients who agreed to participate in the study through the informed consent form (TCLE) in accordance with Resolution 466/12 of the National Health Council.

You may not qualify if:

• Patients who are receiving medication for the treatment and/or prevention of mucositis;
• Patients who were not previously evaluated and released by INCA's Dentistry section team

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (2)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

RECRUITING

Instituto Nacional de Cancer

Rio de Janeiro, 20231-050, Brazil

RECRUITING

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MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization (simple) will be performed in permuted blocks using the REDCap® program, after inclusion in the study, by a member of the non-blinded team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a phase III, double-blind, randomized intervention study that will use the low-power laser device to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B).

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: October 6, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)