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Completed

NCT Number: NCT06003764

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

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

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Key information

Conditions

Dermatitis, Radiation Induced Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ahram canadian University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pulsed Electromagnetic Field

Other

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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

Sponsors and collaborators

Lead sponsor

Ahram Canadian University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2023
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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