RECRUITING

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

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Conditions

Radiation Dermatitis Acuteacute radiation dermatitis (ARD)Silver-plated technology (SPT) dressingadjuvant radiotherapy (RT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06831084

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ECOG ≤ 2
  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. 3. Patients who will receive all of their RT at Magee Women's Hospital.
  4. 4. Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).
  5. 5. Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.
  6. 6. Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.
  7. 7. Must have the ability to understand and the willingness to sign a written informed consent document.
  1. 1. Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
  2. 2. Contraindication to the application of SPT dressing (e.g. allergy).
  3. 3. Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
  4. 4. Planned RT course \>4 weeks or \<3 weeks.
  5. 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. 6. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
  7. 7. Known sensitivity or allergy to silver or nylon.

Contacts and Locations

Study Contact

Samantha Demko, RN
CONTACT
4126231400
albesl@upmc.edu
Brieanna Marino, MS
CONTACT
4126478258
rowlesbm@upmc.edu

Principal Investigator

Parul N Barry, MD
PRINCIPAL_INVESTIGATOR
UPMC Magee-Womens Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Parul Barry

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • acute radiation dermatitis (ARD)
  • Silver-plated technology (SPT) dressing
  • adjuvant radiotherapy (RT)

Additional Relevant MeSH Terms

  • Radiation Dermatitis Acute