NCT05535452

Brief Summary

This is a Randomized Controlled Clinical Trial Women with breast cancer who are indicated for treatment with adjuvant radiotherapy will be eligible. Patients who underwent surgery and/or chemotherapy outside the institution and patients with comprehension difficulties will be excluded. After recruitment, women will be allocated into two groups: intervention (use of LED board) and control (placebo board). The degree of radiodermatitis, pain, edema and/or lymphedema, paresthesia, functionality, quality of life, skin conditions and related independent variables, such as the characteristics of the patient, the tumor and the oncological treatment performed will be evaluated. Thus, the hypothesis of the study is the prevention of radiodermatitis, which is a complication of radiotherapy treatment using photobiomodulation with LED board as a means of intervention.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

August 24, 2022

Last Update Submit

September 6, 2022

Conditions

Radiodermatitis

Keywords

radiotherapyRadiodermatitisphotobiomodulationbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Degree of Radiodermatitis

    Objective scoring of the severity of radiodermatitis using the classification system of the Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC), where the set of skin reactions caused by radiotherapy is classified as grade 0: when there is no reaction; grade 1: mild erythema, epilation and dry flaking; grade 2: painful erythema, moist flaking, and moderate edema; grade 3: wet flaking, confluent and important edema; ulceration, bleeding and necrosis.

    one day, 30 days, 3 and 6 months after radiotherapy treatment

Secondary Outcomes (8)

  • Pain at the application site

    one day, 30 days, 3 and 6 months after radiotherapy treatment

  • Edema/Lymphedema

    one day, 30 days, 3 and 6 months after radiotherapy treatment

  • Paresthesia

    one day, 30 days, 3 and 6 months after radiotherapy treatment

  • Functionality

    one day, 30 days, 3 and 6 months after radiotherapy treatment

  • Skin quality

    one day, 30 days, 3 and 6 months after radiotherapy treatment

  • +3 more secondary outcomes

Study Arms (2)

Group control

PLACEBO COMPARATOR

Patients will receive applications with the LED board turned off without light activation. Applications will be performed within 1 hour after radiotherapy, three times a week, by a trained team, consisting of physical therapists and physical therapy students, and the application time will be the same as in the intervention group. Women will be instructed to maintain specific home exercises for the upper limbs, which are part of the routine of the physiotherapy sector since the first postoperative day at the HCIII/INCA, in addition to their usual physical activities.

Device: Photobiomodulation through LED board

Intervention group

EXPERIMENTAL

At the beginning of radiotherapy treatment, all HCIII/INCA patients are instructed by the nursing team in this sector to use the DNA® ointment provided at the institution and to take proper skin care. Patients identified by the nursing staff with some degree of radiodermatitis undergo treatment with silver sulfadiazine and, if necessary, radiotherapy can be interrupted so that the skin regenerates.

Device: Photobiomodulation through LED board

Interventions

Photobiomodulation through LED boardDEVICE

The applications will be performed within 1 hour after radiotherapy, three times a week, by a trained team, consisting of physiotherapists and physiotherapy students, through the sportllux LED plate equipment, medium size, which combines light emitters in two wavelengths: red (660nm) and infrared (850nm).

Also known as: Light emitting diode
Group controlIntervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen diagnosed with breast cancer and indicated for adjuvant radiotherapy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18 years of age
  • Stage I to IIIC breast cancer
  • Have an indication for adjuvant radiotherapy treatment at HCIII/INCA.

You may not qualify if:

  • have a previous diagnosis of cancer
  • underwent surgery and/or chemotherapy outside the Institution
  • were unable to respond to the questionnaires
  • were unable to receive photobiomodulation due to acute infections will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RadiodermatitisBreast Neoplasms

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast Diseases

Study Officials

  • Rejane M Costa, PhD

    National Cancer Institute - INCA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rejane M Costa, PhD

CONTACT

+55(21)998340428rmcosta2@gmail.com

Daniele M Torres, PhD

CONTACT

+55(21)980755558danieletorres_@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, physiotherapists who supervise the application of the photobiomodulation technique will not be blinded and only patients and evaluators of the results will be blinded to the allocation of the groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: After recruitment, the women will be allocated to: Intervention Group and Control Group. The randomization of the study will be performed in an allocation ratio of 1:1 for the two groups and generated per block of envelopes, sealed and opaque, every 10 patients, which will contain the allocation code (five codes for the intervention group and five codes for the control group). This choice was chosen to avoid influences of the therapist's or patient's preference in relation to the intervention. The patients will be oriented in relation to the group that will be inserted and that the follow-up will be performed while the patient is on radiotherapy and up to three months after treatment. All evaluations, intervention and data collection will be performed by professionals trained and qualified for this purpose.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 10, 2022

Study Start

February 6, 2023

Primary Completion

February 6, 2024

Study Completion

February 6, 2025

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share