Dermatitis, Radiation InducedNCT06003764
Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
A study testing Pulsed electromagnetic field and traditional skin care in people with Dermatitis, Radiation Induced, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Dermatitis, Radiation Induced
- What is being tested?
- Pulsed electromagnetic field and traditional skin care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Jun 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
- Unilateral breast cancer
- Age from 35-55 years.
Who cannot join
- Patients had previous irradiation to the same breast.
- Patients had bilateral breast cancer.
- Patients had metastatic disease.
- when the use of bolus material was required to deliver RT.
- Patients had a pre-existing skin condition or open wound in the treatment area.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.
Read the detailed description
The objective is to understand the effect of PEMF on skin thickness and toxicity after radiotherapy on breast cancer.
The study included 50 adult female breast cancer undergoing whole-breast irradiation.
This is a randomized, controlled clinical trial was conducted at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University, Egypt.
- Conditions
- Dermatitis, Radiation Induced
- Being tested
- Pulsed electromagnetic field, traditional skin care
- Keywords
- PEMFT, DERMATITIS, RADIOTHERAPY
- Medical subject headings
- Radiodermatitis, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fieldOther
low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)
traditional skin careOther
traditional skin care( the patients received the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing was used. Additionally, the patient was advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field group | Experimental | Pulsed electromagnetic Receives: Other: Pulsed electromagnetic field; Other: traditional skin care |
| Placebo group | Placebo comparator | traditional skin care Receives: Other: traditional skin care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography skin thickness measurement.
Ultrasonography was performed before radiotherapy and every two week during radiotherapy, approximately at the same time as skin toxicity assessments.
The machine (L15-4 linear-array transducer; Supersonics Aixplorer; Supersonic Imagine; France) and settings were used for all examinations, including gain, depth and frequency. Exams are performed at room temperature of 20-25°C with the patient supine, hands raised above the head and the ultrasound scans are performed by an experienced sonographer. Standard echo gel is used as a couplant between the skin surface and the probe. To ensure good coupling of the probe/skin interface, in addition to the gel, a sound-guiding pad with a size of 130 × 120 × 10 mm was used. During all examinations, special care was taken to avoid any pressure on the skin surface, and the probe is gently applied to the surface
Measured: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Secondary outcomes (1)
Radiation Therapy Oncology Group (RTOG) SCALE
0 No change
- Faint erythema or dry desquamation
- Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema
- Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
- Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
Measured: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Nov 2023
- Primary completion28 May 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, Radiation InducedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, single blinded controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud H Mohamed, PhD, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003764
- Sponsor's protocol ID
- AhramCU
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed MH, Selim MN, Mohamed ME, Elmeligie MM, Kadry AM, Abdelrazik RK, Samir SM, Kamel RM, Kamal KA, Elshazly M. Efficacy of pulsed electromagnetic field therapy on acute radiodermatitis in breast cancer patients: a randomized controlled study. Support Care Cancer. 2026 Feb 5;34(3):168. doi: 10.1007/s00520-026-10322-9.
PubMed 41642361
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06003764
- Acronym / sponsor ID
- AhramCU
- Conditions
- Dermatitis, Radiation Induced
- Keywords
- PEMFT, DERMATITIS, RADIOTHERAPY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Aug 2023 (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 study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.
Detailed description
The objective is to understand the effect of PEMF on skin thickness and toxicity after radiotherapy on breast cancer.
The study included 50 adult female breast cancer undergoing whole-breast irradiation.
This is a randomized, controlled clinical trial was conducted at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized, single blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field group | Experimental | Other: Pulsed electromagnetic field, Other: traditional skin carePulsed electromagnetic |
| Placebo group | Placebo comparator | Other: traditional skin caretraditional skin care |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
- Unilateral breast cancer
- Age from 35-55 years.
Key exclusion criteria (5 listed)
- Patients had previous irradiation to the same breast.
- Patients had bilateral breast cancer.
- Patients had metastatic disease.
- when the use of bolus material was required to deliver RT.
- Patients had a pre-existing skin condition or open wound in the treatment 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 |
|---|---|---|
| Pulsed electromagnetic fieldlow-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes) | Other | Pulsed electromagnetic field group |
| traditional skin caretraditional skin care( the patients received the institutional standard skin care, which encompassed 3×/day application of topical, hydroactive colloid gel, from the first day of RT. In case of a painful skin reaction and/or moist desquamation, a foam, absorbent, self-adhesive silicone dressing was used. Additionally, the patient was advised to follow the general skin care guidelines (e.g., no tie, no electric shaving, no aftershave, gentle washing with or without mild soap, patting dry with a soft towel instead of rubbing | Other | Placebo group, Pulsed electromagnetic field group |
Primary outcome
Ultrasonography skin thickness measurement.
Time frame: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Ultrasonography was performed before radiotherapy and every two week during radiotherapy, approximately at the same time as skin toxicity assessments. The machine (L15-4 linear-array transducer; Supersonics Aixplorer; Supersonic Imagine; France) and settings were used for all examinations, including gain, depth and frequency. Exams are performed at room temperature of 20-25°C with the patient supine, hands raised above the head and the ultrasound scans are performed by an experienced sonographer. Standard echo gel is used as a couplant between the skin surface and the probe. To ensure good coupling of the probe/skin interface, in addition to the gel, a sound-guiding pad with a size of 130 × 120 × 10 mm was used. During all examinations, special care was taken to avoid any pressure on the skin surface, and the probe is gently applied to the surface
1 secondary outcome
Radiation Therapy Oncology Group (RTOG) SCALE
Time frame: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41642361Mohamed MH, Selim MN, Mohamed ME, Elmeligie MM, Kadry AM, Abdelrazik RK, Samir SM, Kamel RM, Kamal KA, Elshazly M. Efficacy of pulsed electromagnetic field therapy on acute radiodermatitis in breast cancer patients: a randomized controlled study. Support Care Cancer. 2026 Feb 5;34(3):168. doi: 10.1007/s00520-026-10322-9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field and traditional skin care in people with Dermatitis, Radiation Induced, run by Ahram Canadian 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 3 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: finished, as of the sponsor's last update on 13 Aug 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasonography skin thickness measurement. (time frame: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003764, which also lists 1 linked publication.
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 13 Aug 2025.