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Trial Title:
Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
NCT ID:
NCT05535452
Condition:
Radiodermatitis
Conditions: Official terms:
Radiodermatitis
Conditions: Keywords:
radiotherapy
Radiodermatitis
photobiomodulation
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Device
Intervention name:
Photobiomodulation through LED board
Description:
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).
Arm group label:
Group control
Arm group label:
Intervention group
Other name:
Light emitting diode
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.
Detailed description:
Introduction: For Brazil, the INCA estimate is 66,280 new cases of breast cancer for each
year of the 2020-2022 triennium. The treatment of breast cancer depends on the stage of
the disease and the type of tumor. Treatment modalities are divided into systemic
(chemotherapy, hormone therapy and biological therapy) and local (radiotherapy and
surgery) that can be performed alone or in combination, according to clinical and tumor
characteristics. Radiotherapy is associated with some adverse effects, including
radiodermatitis, which is characterized by tissue damage that occurs immediately after
the first radiotherapy session and, as subsequent sessions occur, resulting from dose
fractionation, it starts to the dose accumulates in the skin, which causes the
recruitment of inflammatory cells and the worsening of this complication. General
objective: To evaluate the effectiveness of photobiomodulation with the application of
the LED board in the prevention of radiodermatitis in women with breast cancer undergoing
adjuvant radiotherapy at the Cancer Hospital III of the National Cancer Institute
(HCIII/INCA). Materials and methods: 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women over 18 years of age
- Stage I to IIIC breast cancer
- Have an indication for adjuvant radiotherapy treatment at HCIII/INCA.
Exclusion Criteria:
- 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.
Gender:
Female
Gender based:
Yes
Gender description:
Women diagnosed with breast cancer and indicated for adjuvant radiotherapy
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 6, 2023
Completion date:
February 6, 2025
Lead sponsor:
Agency:
Instituto Nacional de Cancer, Brazil
Agency class:
Other
Source:
Instituto Nacional de Cancer, Brazil
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05535452
