Clinical trial NCT05535452: Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
Official title: Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiodermatitis
Keywords: radiotherapy
Radiodermatitis
photobiomodulation
breast cancer
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2022-09-10
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

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.

Primary outcomes:
measure: Degree of Radiodermatitis
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Secondary outcomes:
measure: Pain at the application site
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Edema/Lymphedema
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Paresthesia
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Functionality
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Skin quality
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Questionnaire about Health-related quality of life
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Questionnaire about Satisfaction with photobiomodulation
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
measure: Questionnaire about Impact of radiodermatitis
timeFrame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute - INCA
name: Rejane M Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: