RadiodermatitisNCT05535452
Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
A study testing Photobiomodulation through LED board in people with Radiodermatitis, run by Instituto Nacional de Cancer, Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Photobiomodulation through LED board
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2023to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years of age
- Stage I to IIIC breast cancer
- Have an indication for adjuvant radiotherapy treatment at HCIII/INCA.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Radiodermatitis
- Being tested
- Photobiomodulation through LED board
- Keywords
- radiotherapy, Radiodermatitis, photobiomodulation, breast cancer
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation through LED boardDevice
Also called Light emitting diode
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation through LED board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Secondary outcomes (8)
Pain at the application site
Pain - pain assessment using the visual analog scale (VAS). Pain will be assessed weekly by the patient. Patients will respond to the visual analog scale modified for pain (self-assessment of the patient).
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Edema/Lymphedema
Edema/Lymphedema: Edema or lymphedema in the upper limb homolateral to axillary breast cancer surgery will be evaluated by perimetry in the upper limbs. The points of the measurements will be: elbow joint interline (IAC), 07 cm above the IAC, 14 cm above the IAC, 7 cm below the IAC, 14 cm below the IAC, 21 cm below the IAC and back of the hand. The total volume of the limb will be calculated by the cone trunk formula, using the circumference measurements:
V = h * (C² + Cc + c²) / (- * 12). Where, V is the total volume, C and c are the circumferences between the measured points and h is the distance between the circumferences in each segment. Lymphedema will be considered when the total volume is 200 ml between the affected limb and the contralateral limb, 6 months after surgical treatment. Edema will be considered when the total volume is 200 ml in the first six months after surgery.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Paresthesia
It can be evaluated using the Stesiometer (monofilaments) . Patients will be evaluated in a quiet and comfortable environment with as little interference as possible; will face the examiner with the hand or foot supported; the test will be demonstrated to the patient using an area of skin with normal sensitivity; patients will be blinded or instructed to close their eyes; the test will start following the specific technique according to the instrument used; the points tested will be previously determined. The testing sequence can be random.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Functionality
DASH Questionnaire. This questionnaire is about symptoms as well as skills to do certain activities. Must be answered with regards to last week's physical condition. If you were unable to perform physical activity in the past week, estimate which answer would be correct. It doesn't matter which hand or arm is used to do the activity, the response is based on skill regardless of how the task is performed. It has 30 questions and two optional modules and uses a 5-point scale and the total score ranges from 0 (no dysfunction) to 100 (severe dysfunction).
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Skin quality
Skindex: Questionnaire used to evaluate patients with any skin alteration and allows identifying how they evolve over time after treatment. In this scale, responses are reported on 3 scales or dimensions: physical (items number 1 to 4), emotions (items number 5 to 11) and functionality (items number 12 to 16). Responses are given on a 7-point Likert-type scale, ranging from 0 ("never bothered") to 6 ("always bothered"), according to the intensity of the frequency with which the patient was bothered, due to his skin condition during the last seven days. All responses are transformed into a linear scale ranging from 0 to 100. The scores for each of the 3 domains (symptoms, emotions and functionality) are calculated. The higher the value found, the worse the quality of life.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Health-related quality of life
will be the EORTC QLQ-C30 3rd version, translated into Portuguese, multidimensional and self-administered, which includes 30 questions related to five functional scales (physical, functional, emotional, social and cognitive), a scale on health status assessment, three symptom scales (fatigue, pain, and nausea/vomiting) and six additional symptom items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). And the specific quality of life questionnaire for breast cancer patients, the EORTC QLQ-BR23, translated into Portuguese, which contains 23 questions related to a functional scale (body image, sexual function, sexual pleasure and future perspectives) and a scale of symptoms (side effects of systemic therapy, breast symptoms, arm symptoms and hair loss). Both questionnaires will be applied in relation to the last week of the patient and both were translated and validated into Portuguese.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Satisfaction with photobiomodulation
Self-report on efficacy and overall satisfaction with the management of radiodermatitis.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Impact of radiodermatitis
Self-report on the impact of radiodermatitis on activities of daily living.
Measured: one day, 30 days, 3 and 6 months after radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start6 Feb 2023 (estimated)
- Primary completion6 Feb 2024 (estimated)
- Study completion6 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rejane Medeiros Costa, Instituto Nacional de Cancer, Brazil
- Investigators
- Rejane M Costa, PhD, Principal investigator, National Cancer Institute - INCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535452
- Sponsor's protocol ID
- Prevention of radiodermatitis
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Prevention of Radiodermatitis in Women With Breast Cancer Undergoing Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT05535452
- Acronym / sponsor ID
- Prevention of radiodermatitis
- Conditions
- Radiodermatitis
- Keywords
- radiotherapy, Radiodermatitis, photobiomodulation, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 6 Feb 2023 (estimated)
- Primary completion
- 6 Feb 2024 (estimated)
- Study completion
- 6 Feb 2025 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group control | Placebo comparator | Device: Photobiomodulation through LED boardPatients 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. |
| Intervention group | Experimental | Device: Photobiomodulation through LED boardAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18 years of age
- Stage I to IIIC breast cancer
- Have an indication for adjuvant radiotherapy treatment at HCIII/INCA.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation through LED boardAlso: Light emitting diodeThe 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). | Device | Group control, Intervention group |
Primary outcome
Degree of Radiodermatitis
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
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.
8 secondary outcomes
Pain at the application site
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Edema/Lymphedema
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Paresthesia
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Functionality
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Skin quality
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Health-related quality of life
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Satisfaction with photobiomodulation
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Questionnaire about Impact of radiodermatitis
Time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rejane M Costa, PhD principal investigator
National Cancer Institute - INCA
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation through LED board in people with Radiodermatitis, run by Instituto Nacional de Cancer, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rejane M Costa, PhD (+55(21)998340428, rmcosta2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Radiodermatitis (time frame: one day, 30 days, 3 and 6 months after radiotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.