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

NCT ID: NCT06003764

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-06-30

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 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.

Conditions

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Dermatitis, Radiation Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, single blinded controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pulsed electromagnetic field group

Pulsed electromagnetic

Group Type EXPERIMENTAL

Pulsed electromagnetic field

Intervention Type OTHER

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

traditional skin care

Intervention Type 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

traditional skin care

Group Type PLACEBO_COMPARATOR

traditional skin care

Intervention Type 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

Interventions

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Pulsed electromagnetic field

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

Intervention Type OTHER

traditional skin care

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

Intervention Type OTHER

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud H Mohamed, PhD

Assistant Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ahram canadian University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AhramCU

Identifier Type: -

Identifier Source: org_study_id

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