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

Not Applicable

Completed

• Conditions: Dermatitis, Radiation Induced
• Interventions: Other: Pulsed electromagnetic field; Other: traditional skin care

• Registration Number: NCT06003764
• Lead Sponsor: Ahram Canadian University

Brief Summary

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 will include 50 adult female breast cancer undergoing whole-breast irradiation.

This is a randomized, controlled clinical trial will conduct at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University.

Study Timeline

• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-22
• Study Start: 2023-11-01
• Primary Completion: 2024-05-28
• Status Verified: 2024-07
• Study Completion: 2024-07-10
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed electromagnetic field group	Pulsed electromagnetic field	Pulsed electromagnetic
Pulsed electromagnetic field group	traditional skin care	Pulsed electromagnetic
Placebo group	traditional skin care	traditional skin care

Primary Outcome Measures

Name	Time	Method
Ultrasonography skin thickness measurement.	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 Outcome Measures

Name	Time	Method
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.	0 No change; 1. Faint erythema or dry desquamation; 2. Moderate to brisk erythema; patchy, moist desquamation, mostly confined to skin folds and creases; moderate edema; 3. Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; 4. Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated

Trial Locations

Locations (1)

ahram canadian University; 🇪🇬 Giza, Egypt