Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology

Description

Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.

Conditions

Radiation Dermatitis Acute

Study Overview

Study Details

Study overview

Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.

Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial

Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology

Condition
Radiation Dermatitis Acute
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ECOG ≤ 2
  • 2. Male or female patients with breast cancer or breast carcinoma in situ who are recommended to receive adjuvant radiotherapy to the breast +/- regional lymph nodes or are planned to receive adjuvant radiotherapy to the chest wall and regional lymph nodes over 3 to 4 weeks.
  • 3. Patients who will receive all of their RT at Magee Women's Hospital.
  • 4. Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).
  • 5. Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.
  • 6. Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.
  • 7. Must have the ability to understand and the willingness to sign a written informed consent document.
  • 1. Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
  • 2. Contraindication to the application of SPT dressing (e.g. allergy).
  • 3. Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
  • 4. Planned RT course \>4 weeks or \<3 weeks.
  • 5. Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash in the area that will receive RT, systemic lupus erythematosis, or scleroderma.
  • 6. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
  • 7. Known sensitivity or allergy to silver or nylon.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Parul Barry,

Parul N Barry, MD, PRINCIPAL_INVESTIGATOR, UPMC Magee-Womens Hospital

Study Record Dates

2026-05-31