- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561803
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.
March 9, 2024 updated by: Rebeca Boltes Cecatto, University of Nove de Julho
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brazil
- Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Outpatient cancer patients on palliative care undergoing radiotherapy and who show signs of radiodermatitis RTOG II OR III.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from Baseline at 14 days after end of radiotherapy treatment]
|
Lesion Size
Time Frame: Change from Baseline at 14 days after end of radiotherapy treatment]
|
Evaluation of lesion measurement in centimeters
|
Change from Baseline at 14 days after end of radiotherapy treatment]
|
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,
|
Change from Baseline at 14 days after end of radiotherapy treatment]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale of Pain
Time Frame: Change from Baseline at 14 days after end of radiotherapy treatment]
|
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').
|
Change from Baseline at 14 days after end of radiotherapy treatment]
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete blood count (CBC)
Time Frame: Change from Baseline at 14 days after end of radiotherapy treatment]
|
A complete blood count test measures components and features of blood, including: red blood cells, white blood cells, hemoglobin, Hematocrit, Platelets.
|
Change from Baseline at 14 days after end of radiotherapy treatment]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebeca B Cecatto, Ph.D., University of Nove de Julho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 8, 2024
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
September 27, 2022
First Posted (Actual)
September 30, 2022
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiodermatitistalita30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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