Radiodermatitis; AcuteNCT05561803
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
An observational study of Radiodermatitis; Acute and Radiotherapy Side Effect, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiodermatitis; Acute, Radiotherapy Side Effect, Cancer Patients
- What is being tested?
- Photobiomodulation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2024to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatient cancer patients on palliative care undergoing radiotherapy and who show signs of radiodermatitis RTOG II OR III.
Who may be able to join
- Older than 18 years;
- Patients with any oncological etiology;
- With the presence of established radiodermatitis RTOG II or III;
- Patients who are undergoing palliative oncological care and RD standard treatment;
- Patients who do not present clinical signs of another pathology that justifies the presence of the skin lesion;
- Patients do not have local skin infection
Who cannot join
- Critical clinical states;
- Patients with skin lesions of another cause even when undergoing RT;
- Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.
- Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.
- All contraindications already defined in the routine referral to the outpatient clinic (patients who have an active tumor at the site to be irradiated; individuals with a history of photosensitivity to photonic or light therapy; patients who have undiagnosed lesions in the treatment region; patients using topical photosensitizing medications or creams; cognitive, psychiatric or neurological changes that prevent the free understanding of the PBM therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
São Paulo, São Paulo
About this study
It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis on Palliative Care, treated with PBM. This is a case series report and the study data will be extracted from the medical records of forty cancer patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.
Read the detailed description
It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of forty cancer patients on palliative care diagnosed with radiotherapy-induced acute radiodermatitis Grade 2or 3, treated with PBM. This is a case series report and the study data will be extracted from the medical records of patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 685 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.
- Being tested
- Photobiomodulation Therapy
- Keywords
- Radiodermatitits, Radiotherapy, Photobiomodulation, Cancer, Palliative Care
- Medical subject headings
- Radiodermatitis, Radiation Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyRadiation
Also called PBM Therapy
Focal low-level laser therapy, Red Laser (wavelength 633 nm to 685 nm), or Infrared Laser Laser (wavelength 780 nm to 830 nm), with a low-intensity laser equipment of 100 mW and a cross-sectional area of the device beam of 0.0434 cm². The parameters are 1 to 3 J per point, with equidistant points of 1.5 to 2 cm, covering the entire length of the open lesion. Therapy is carried out every 48 hours until the total wound healing, regardless of the number of sessions required.
| Study group | Role | What they receive |
|---|---|---|
| Radiodermatitis Case Group | 40 patients on palliative care with grade 2 or grade 3 radiodermatitis after radiotherapy for the treatment of cancer submitted to a PBM therapy protocol Receives: Radiation: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)
RTOG scale assess the degree and intensity of RD. It identifies degree 0 (no reaction), 1 (faint erythema, dry desquamation, epilation, diminished sweating), 2 (moderate, brisk erythema, exudative dermatitis in plaques and moderate edema), 3 (exudative dermatitis, besides cutaneous folds and intense edema) and 4 (ulceration, hemorrhage, necrosis).
Measured: Change from Baseline at 14 days after end of radiotherapy treatment]
Lesion Size
Evaluation of lesion measurement in centimeters
Measured: Change from Baseline at 14 days after end of radiotherapy treatment]
Portuguese version of The World Health Organization Quality of Life Scale (WHOQOL-BREF)
The WHOWOL BREF scale assess multidimensional aspects of geral quality of life of patients. The multidimensional scale is composed by 26 items, classified from 1 to 5 according to the intensity of the symptom presented. The global score is calculated by adding up all the items as well as the score for each domain is evaluated adding it individually for each item, which can range from 0 to 130,
Measured: Change from Baseline at 14 days after end of radiotherapy treatment]
Secondary outcomes (1)
Visual Analog Scale of Pain
VAS Scale assess the pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Change from Baseline at 14 days after end of radiotherapy treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start8 Apr 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Research team withdrawn the study before starting the recruitment because the university suspended the service for administrative restructuring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiodermatitis; AcuteStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
- Investigators
- Rebeca B Cecatto, Ph.D., Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561803
- Sponsor's protocol ID
- Radiodermatitistalita30
- Status last verified
- Mar 2024
- First submitted
- 27 Sep 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
- ClinicalTrials.gov ID
- NCT05561803
- Acronym / sponsor ID
- Radiodermatitistalita30
- Keywords
- Radiodermatitits, Radiotherapy, Photobiomodulation, Cancer, Palliative Care
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Research team withdrawn the study before starting the recruitment because the university suspended the service for administrative restructuring
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 8 Apr 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 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.
It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis on Palliative Care, treated with PBM. This is a case series report and the study data will be extracted from the medical records of forty cancer patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.
Detailed description
It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of forty cancer patients on palliative care diagnosed with radiotherapy-induced acute radiodermatitis Grade 2or 3, treated with PBM. This is a case series report and the study data will be extracted from the medical records of patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 685 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiodermatitis Case Group | – | Radiation: Photobiomodulation Therapy40 patients on palliative care with grade 2 or grade 3 radiodermatitis after radiotherapy for the treatment of cancer submitted to a PBM therapy protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient cancer patients on palliative care undergoing radiotherapy and who show signs of radiodermatitis RTOG II OR III.
Key inclusion criteria (6 listed)
- Older than 18 years;
- Patients with any oncological etiology;
- With the presence of established radiodermatitis RTOG II or III;
- Patients who are undergoing palliative oncological care and RD standard treatment;
- Patients who do not present clinical signs of another pathology that justifies the presence of the skin lesion;
Key exclusion criteria (5 listed)
- Critical clinical states;
- Patients with skin lesions of another cause even when undergoing RT;
- Patients referred to the laser clinic for the prevention of radiodermatitis without the active RD lesion.
- Patients who have used another photobiomodulation therapy protocol foresaw injury not related to the study.
- All contraindications already defined in the routine referral to the outpatient clinic (patients who have an active tumor at the site to be irradiated; individuals with a history of photosensitivity to photonic or light therapy; patients who have undiagnosed lesions in the treatment region; patients using topical photosensitizing medications or creams; cognitive, psychiatric or neurological changes that prevent the free understanding of the PBM therapy
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 TherapyAlso: PBM TherapyFocal low-level laser therapy, Red Laser (wavelength 633 nm to 685 nm), or Infrared Laser Laser (wavelength 780 nm to 830 nm), with a low-intensity laser equipment of 100 mW and a cross-sectional area of the device beam of 0.0434 cm². The parameters are 1 to 3 J per point, with equidistant points of 1.5 to 2 cm, covering the entire length of the open lesion. Therapy is carried out every 48 hours until the total wound healing, regardless of the number of sessions required. | Radiation | Radiodermatitis Case Group |
Primary outcome
Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale)
Time frame: Change from Baseline at 14 days after end of radiotherapy treatment]
RTOG scale assess the degree and intensity of RD. It identifies degree 0 (no reaction), 1 (faint erythema, dry desquamation, epilation, diminished sweating), 2 (moderate, brisk erythema, exudative dermatitis in plaques and moderate edema), 3 (exudative dermatitis, besides cutaneous folds and intense edema) and 4 (ulceration, hemorrhage, necrosis).
Lesion Size
Time frame: Change from Baseline at 14 days after end of radiotherapy treatment]
Evaluation of lesion measurement in centimeters
Portuguese version of The World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: Change from Baseline at 14 days after end of radiotherapy treatment]
The WHOWOL BREF scale assess multidimensional aspects of geral quality of life of patients. The multidimensional scale is composed by 26 items, classified from 1 to 5 according to the intensity of the symptom presented. The global score is calculated by adding up all the items as well as the score for each domain is evaluated adding it individually for each item, which can range from 0 to 130,
1 secondary outcome
Visual Analog Scale of Pain
Time frame: Change from Baseline at 14 days after end of radiotherapy treatment]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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.
Rebeca B Cecatto, Ph.D. principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiodermatitis; Acute and Radiotherapy Side Effect, run by University of Nove de Julho at 1 site in 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity criteria of the Radiation Therapy Oncology Group Scale (RTOG Scale) (time frame: Change from Baseline at 14 days after end of radiotherapy treatment]). The study lists 3 primary outcomes in all. 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 12 Mar 2024.