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

Primary Purpose

Dermatitis, Radiation Induced

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed electromagnetic field
traditional skin care
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Radiation Induced focused on measuring PEMFT, DERMATITIS, RADIOTHERAPY

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • ahram canadian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pulsed electromagnetic field group

Placebo group

Arm Description

low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes) A magnetotherapy device will be used for the PEMFT was ASTAR Magneto-therapy premium (15 Hz, 1.5 mT intensity output for 5 s/min for 20 min. 3 times per week for 8 successive weeks plus 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). for 8 successive weeks

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). for 8 successive weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2023
Last Updated
August 18, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT06003764
Brief Title
Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
Official Title
Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Radiation Induced
Keywords
PEMFT, DERMATITIS, RADIOTHERAPY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, single blinded controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed electromagnetic field group
Arm Type
Experimental
Arm Description
low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes) A magnetotherapy device will be used for the PEMFT was ASTAR Magneto-therapy premium (15 Hz, 1.5 mT intensity output for 5 s/min for 20 min. 3 times per week for 8 successive weeks plus 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). for 8 successive weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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). for 8 successive weeks
Intervention Type
Other
Intervention Name(s)
Pulsed electromagnetic field
Intervention Description
low-frequency PEMFT (15 Hz, 50% intensity output for 5 s/min for 20 minutes)
Intervention Type
Other
Intervention Name(s)
traditional skin care
Intervention Description
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
Primary Outcome Measure Information:
Title
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) SCALE
Description
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
Time Frame
pre treatment and post 2 months of treatment
Secondary Outcome Measure Information:
Title
Radiation Therapy Oncology Group (RTOG) SCALE
Description
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
Time Frame
pre treatment and post 2 months of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females with Breast cancer
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud hamada, Assisyant Professor
Phone
01096968910
Email
dr.mahmoudhamada@acu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed naeem, Mahmoud Abdel Tawab Mahmoud
Phone
0106739576
Email
mohamed.naeem@pt.bsu.edu.eg
Facility Information:
Facility Name
ahram canadian University
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed selim, PhD
First Name & Middle Initial & Last Name & Degree
mahmoud Abdel Tawab, PhD
First Name & Middle Initial & Last Name & Degree
Abdelrazak Ahmed, PhD
First Name & Middle Initial & Last Name & Degree
mahmoud elshazly, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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