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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Radiation Induced
• Intervention / Treatment: Other: Pulsed electromagnetic field; Other: traditional skin care

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mahmoud hamada, Assisyant Professor; Phone Number: 01096968910; Email: dr.mahmoudhamada@acu.edu.eg
• Study Contact Backup: Name: mohamed naeem, Mahmoud Abdel Tawab Mahmoud; Phone Number: 0106739576; Email: mohamed.naeem@pt.bsu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Ahram Canadian University
    • Sub-Investigator: mohamed selim, PhD
    • Sub-Investigator: mahmoud Abdel Tawab, PhD
    • Sub-Investigator: Abdelrazak Ahmed, PhD
    • Sub-Investigator: mahmoud elshazly, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed electromagnetic field group; Pulsed electromagnetic	Other: Pulsed electromagnetic field; low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes); Other: traditional skin care; traditional skin care( the patients will receive 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 will be used. Additionally, the patient will be 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 Comparator: Placebo group; traditional skin care	Other: traditional skin care; traditional skin care( the patients will receive 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 will be used. Additionally, the patient will be 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 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	pre treatment and post 2 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre treatment and post 2 months of treatment

Collaborators and Investigators

• Sponsor: Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: PEMFT, DERMATITIS, RADIOTHERAPY
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: AhramCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No