Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients

NCT06003764 | Completed DMC

• 1 other identifier: AhramCU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.

Conditions

Dermatitis, Radiation Induced

Keywords

PEMFT, DERMATITIS, RADIOTHERAPY

Outcome Measures

Primary Outcomes (1)

• 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

  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

  pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.

Study Arms (2)

Pulsed electromagnetic field group

EXPERIMENTAL

Pulsed electromagnetic

Other: Pulsed electromagnetic field; Other: traditional skin care

Placebo group

PLACEBO COMPARATOR

traditional skin care

Other: traditional skin care

Interventions

Pulsed electromagnetic field OTHER

low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)

Pulsed electromagnetic field group

traditional skin care OTHER

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

Placebo group; Pulsed electromagnetic field group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: females with Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
• Unilateral breast cancer
• Age from 35-55 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

ahram canadian University

Giza, Egypt

Location

MeSH Terms

Conditions

Radiodermatitis; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Model Details: randomized, single blinded controlled trial

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 22, 2023
• Study Start: November 1, 2023
• Primary Completion: May 28, 2024
• Study Completion: June 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)