Radio DermatitisPLARD-BREASTNCT07600957
Polarized Light Therapy for Radiation Dermatitis in Breast Cancer
A study testing Polarized Polychromatic Light Therapy and Standard Skin Care in people with Radio Dermatitis and Polarized Light, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This assessor-blinded randomized controlled trial aims to evaluate the efficacy of polarized polychromatic non-coherent light therapy as an adjunct to standard skin care in reducing acute radiation dermatitis in women with breast cancer undergoing hypofractionated whole-breast radiotherapy. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Radio Dermatitis, Polarized Light, Breast Cancer Survivors
- What is being tested?
- Polarized Polychromatic Light Therapy and Standard Skin Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 35-55 years.
- Histologically confirmed primary unilateral breast cancer.
- Status post breast-conserving surgery (lumpectomy).
- Planned for hypo fractionated whole-breast irradiation (HFWBI).
- Scheduled to receive a total radiation dose of 40-42.5 Gy delivered in 15-16 fractions over approximately 3 weeks.
- Ability to understand study procedures and provide written informed consent.
Who cannot join
- Previous radiotherapy to the same breast or thoracic region.
- Bilateral breast cancer.
- Metastatic or advanced systemic disease.
- Prior mastectomy.
- Active skin infection in the irradiated area.
- Pre-existing dermatologic disorders affecting the breast skin (e.g., eczema, psoriasis, dermatitis).
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- Concurrent chemotherapy during radiotherapy.
- Presence of cardiac pacemaker or implantable electronic device in the treatment field.
- Open wounds or ulceration in the irradiated breast region.
- Any medical condition judged by the investigator to interfere with study participation or outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Out patient clinic , faculty of Physical Therapy, Beni Sueif university
Banī Suwayf
Marwa Elsayed Mohamed Lecturer, Ph.D, 01141825442, Marwa.elsayed@pt.bsu.edu.eg
About this study
Official title: Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial
This assessor-blinded randomized controlled trial aims to evaluate the efficacy of polarized polychromatic non-coherent light therapy as an adjunct to standard skin care in reducing acute radiation dermatitis in women with breast cancer undergoing hypofractionated whole-breast radiotherapy. Participants will be randomly allocated to receive either standard skin care alone or standard care combined with polarized light therapy initiated from the first radiotherapy session. Outcomes will include objective ultrasound-based dermal thickness measurements, clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria.
Read the detailed description
Acute radiation dermatitis is one of the most frequent adverse effects associated with breast cancer radiotherapy and may negatively affect patient comfort, treatment adherence, and quality of life. Clinical manifestations range from mild erythema and dry desquamation to severe moist desquamation and ulceration. Although standard skin care measures are routinely implemented, effective preventive and therapeutic non-invasive interventions remain limited.
Polarized polychromatic non-coherent light therapy has demonstrated anti-inflammatory, microcirculatory, tissue regenerative, and wound-healing effects in several dermatologic and musculoskeletal conditions. However, evidence regarding its efficacy for radiation-induced skin toxicity remains insufficient.
This prospective randomized assessor-blinded controlled trial will investigate the effectiveness of polarized light therapy as an adjunctive supportive treatment for acute radiation dermatitis in women receiving hypo fractionated whole-breast irradiation (40-42.5 Gy in 15-16 fractions over approximately 3 weeks) following breast-lumpectomy for breast cancer.
Participants will be randomly assigned into two parallel groups:
- Polarized light therapy plus Standard skin care.
- Standard skin care alone. The polarized light intervention will be initiated on the first day of radiotherapy and administered three times weekly throughout the radiotherapy course using the Bioptron Light Therapy System.
The primary outcome will be ultrasound-based dermal thickness changes within the irradiated breast region. Secondary outcomes will include clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria Assessments will be conducted at baseline, Week 2, Week 4, Week 6, Week 8, and at 2-month follow-up. The study aims to determine whether polarized light therapy can reduce radiation-induced skin inflammation, delay progression of dermatitis severity, improve symptom burden, and enhance skin recovery compared with standard care alone.
- Conditions
- Radio Dermatitis, Polarized Light, Breast Cancer Survivors
- Being tested
- Polarized Polychromatic Light Therapy, Standard Skin Care
- Keywords
- hypo fractionated whole-breast irradiation, radiodermatitis, polarized light therapy, ultrasound scan
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarized Polychromatic Light TherapyDevice
Polarized polychromatic non-coherent light therapy will be administered using the Bioptron Light Therapy System. The device emits light with a wavelength spectrum ranging from 480-3400 nm, polarization >95%, and irradiance approximately 40 mW/cm². Treatment will be applied perpendicular to the irradiated breast skin surface from a distance of approximately 10 cm for 6-10 minutes per treatment field, corresponding to an estimated fluence of approximately 2.4 J/cm² per minute. Sessions will be administered three times weekly on alternating days beginning from the first radiotherapy session and continuing throughout the radiotherapy course. The entire irradiated breast field will be treated.
Standard Skin CareOther
Routine institutional radiation skin care protocol including conventional skin care initiated from the first day of radiotherapy, with application of hydroactive colloid gel for three days as needed. An absorbent foam self-adhesive silicone dressing will be used in cases of painful skin reactions or moist desquamation. Participants will also receive standardized skin care instructions including gentle washing with mild soap or water only, patting the skin dry with a soft absorbent towel rather than rubbing, maintenance of skin hydration, and avoidance of friction, tight clothing, perfumes, and other potential skin irritants throughout the radiotherapy course.
| Study group | Role | What they receive |
|---|---|---|
| Polarized Light Therapy + Standard Care | Experimental | Participants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course. Receives: Device: Polarized Polychromatic Light Therapy; Other: Standard Skin Care |
| Standard Care Alone | Other | Participants will receive standard institutional skin care management during radiotherapy. Receives: Other: Standard Skin Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Skin Thickness
Objective assessment of radiation-induced skin structural changes using high-frequency musculoskeletal ultrasound imaging of the irradiated breast region. Dermal thickness measurements (mm) will be performed by the same radiologist for both groups throughout the study. A standardized layer of ultrasound gel approximately 1 mm thick will be used as a coupling medium to optimize image acquisition. Measurements will be obtained from the most clinically affected area within the irradiated breast field. To improve accuracy and reliability, the average of three consecutive measurements will be recorded for analysis. Special care will be taken to avoid compression artifacts by gently applying the ultrasound probe to the skin surface with minimal pressure.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
Secondary outcomes (1)
Radiation Therapy Oncology Group (RTOG) Severity
Clinical severity of acute radiation dermatitis will be assessed using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. Skin reactions within the irradiated breast area will be evaluated and classified according to the degree of skin irritation and tissue damage as follows: RTOG Grade 0: no visible skin change; Grade 1: mild erythema, epilation, sweating, or dry desquamation; Grade 2: bright or painful erythema, patchy moist desquamation, or moderate edema; Grade 3: confluent moist desquamation extending beyond skin folds and pitting edema; Grade 4: ulceration, necrosis, or bleeding. Assessments will be conducted by a blinded assessor under standardized clinical conditions throughout the study period. Scoring criteria ranging from Grade 0 to Grade 4.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start21 May 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radio DermatitisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 ratio into either an experimental group receiving polarized light therapy in addition to standard skin care or a control group receiving standard skin care alone throughout the radiotherapy course.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Mohamed, PhD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600957
- Sponsor's protocol ID
- Polarized light Dermatitis 26
- Acronym
- PLARD-BREAST
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polarized Polychromatic Light Therapy on Acute Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07600957
- Acronym / sponsor ID
- PLARD-BREAST / Polarized light Dermatitis 26
- Conditions
- Radio Dermatitis, Polarized Light, Breast Cancer Survivors
- Keywords
- hypo fractionated whole-breast irradiation, radiodermatitis, polarized light therapy, ultrasound scan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 May 2026 (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 assessor-blinded randomized controlled trial aims to evaluate the efficacy of polarized polychromatic non-coherent light therapy as an adjunct to standard skin care in reducing acute radiation dermatitis in women with breast cancer undergoing hypofractionated whole-breast radiotherapy. Participants will be randomly allocated to receive either standard skin care alone or standard care combined with polarized light therapy initiated from the first radiotherapy session. Outcomes will include objective ultrasound-based dermal thickness measurements, clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria.
Detailed description
Acute radiation dermatitis is one of the most frequent adverse effects associated with breast cancer radiotherapy and may negatively affect patient comfort, treatment adherence, and quality of life. Clinical manifestations range from mild erythema and dry desquamation to severe moist desquamation and ulceration. Although standard skin care measures are routinely implemented, effective preventive and therapeutic non-invasive interventions remain limited.
Polarized polychromatic non-coherent light therapy has demonstrated anti-inflammatory, microcirculatory, tissue regenerative, and wound-healing effects in several dermatologic and musculoskeletal conditions. However, evidence regarding its efficacy for radiation-induced skin toxicity remains insufficient.
This prospective randomized assessor-blinded controlled trial will investigate the effectiveness of polarized light therapy as an adjunctive supportive treatment for acute radiation dermatitis in women receiving hypo fractionated whole-breast irradiation (40-42.5 Gy in 15-16 fractions over approximately 3 weeks) following breast-lumpectomy for breast cancer.
Participants will be randomly assigned into two parallel groups:
- Polarized light therapy plus Standard skin care.
- Standard skin care alone. The polarized light intervention will be initiated on the first day of radiotherapy and administered three times weekly throughout the radiotherapy course using the Bioptron Light Therapy System.
The primary outcome will be ultrasound-based dermal thickness changes within the irradiated breast region. Secondary outcomes will include clinical severity of radiation dermatitis using Radiation Therapy Oncology Group (RTOG) criteria Assessments will be conducted at baseline, Week 2, Week 4, Week 6, Week 8, and at 2-month follow-up. The study aims to determine whether polarized light therapy can reduce radiation-induced skin inflammation, delay progression of dermatitis severity, improve symptom burden, and enhance skin recovery compared with standard care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 ratio into either an experimental group receiving polarized light therapy in addition to standard skin care or a control group receiving standard skin care alone throughout the radiotherapy course.
| Arm | Type | Receives |
|---|---|---|
| Polarized Light Therapy + Standard Care | Experimental | Device: Polarized Polychromatic Light Therapy, Other: Standard Skin CareParticipants will receive polarized polychromatic non-coherent light therapy combined with routine institutional skin care management during the radiotherapy course. |
| Standard Care Alone | Other | Other: Standard Skin CareParticipants will receive standard institutional skin care management during radiotherapy. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients aged 35-55 years.
- Histologically confirmed primary unilateral breast cancer.
- Status post breast-conserving surgery (lumpectomy).
- Planned for hypo fractionated whole-breast irradiation (HFWBI).
- Scheduled to receive a total radiation dose of 40-42.5 Gy delivered in 15-16 fractions over approximately 3 weeks.
Key exclusion criteria (10 listed)
- Previous radiotherapy to the same breast or thoracic region.
- Bilateral breast cancer.
- Metastatic or advanced systemic disease.
- Prior mastectomy.
- Active skin infection in the irradiated area.
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 |
|---|---|---|
| Polarized Polychromatic Light TherapyPolarized polychromatic non-coherent light therapy will be administered using the Bioptron Light Therapy System. The device emits light with a wavelength spectrum ranging from 480-3400 nm, polarization >95%, and irradiance approximately 40 mW/cm². Treatment will be applied perpendicular to the irradiated breast skin surface from a distance of approximately 10 cm for 6-10 minutes per treatment field, corresponding to an estimated fluence of approximately 2.4 J/cm² per minute. Sessions will be administered three times weekly on alternating days beginning from the first radiotherapy session and continuing throughout the radiotherapy course. The entire irradiated breast field will be treated. | Device | Polarized Light Therapy + Standard Care |
| Standard Skin CareRoutine institutional radiation skin care protocol including conventional skin care initiated from the first day of radiotherapy, with application of hydroactive colloid gel for three days as needed. An absorbent foam self-adhesive silicone dressing will be used in cases of painful skin reactions or moist desquamation. Participants will also receive standardized skin care instructions including gentle washing with mild soap or water only, patting the skin dry with a soft absorbent towel rather than rubbing, maintenance of skin hydration, and avoidance of friction, tight clothing, perfumes, and other potential skin irritants throughout the radiotherapy course. | Other | Polarized Light Therapy + Standard Care, Standard Care Alone |
Primary outcome
Ultrasound Skin Thickness
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
Objective assessment of radiation-induced skin structural changes using high-frequency musculoskeletal ultrasound imaging of the irradiated breast region. Dermal thickness measurements (mm) will be performed by the same radiologist for both groups throughout the study. A standardized layer of ultrasound gel approximately 1 mm thick will be used as a coupling medium to optimize image acquisition. Measurements will be obtained from the most clinically affected area within the irradiated breast field. To improve accuracy and reliability, the average of three consecutive measurements will be recorded for analysis. Special care will be taken to avoid compression artifacts by gently applying the ultrasound probe to the skin surface with minimal pressure.
1 secondary outcome
Radiation Therapy Oncology Group (RTOG) Severity
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polarized Polychromatic Light Therapy and Standard Skin Care in people with Radio Dermatitis and Polarized Light, run by Beni-Suef University at 1 site in Egypt.
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 10 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Elsayed Mohamed Lecturer, Ph.D (01141825442, Marwa.elsayed@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Skin Thickness (time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and 2-month follow-up.). 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 26 May 2026.