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

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

Detailed Description
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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.

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

Conditions
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Dermatitis, Radiation Induced

Intervention / Treatment
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* Other: Pulsed electromagnetic field
* Other: traditional skin care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, single blinded controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed electromagnetic field group<br>Pulsed electromagnetic | Other: Pulsed electromagnetic field<br>* low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)<br>Other: traditional skin care<br>* 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<br>|
| Placebo Comparator: Placebo group<br>traditional skin care | Other: traditional skin care<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEMFT, DERMATITIS, RADIOTHERAPY