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Completed

NCT Number: NCT04238728

Silverlon to Reduce Radiation Dermatitis

The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum Medical) is useful for the prevention or treatment of radiation dermatitis in patients receiving radiation therapy to the breast.

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Key information

Age range

22 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females, 22 years of age or older, with diagnosis of primary breast cancer (excluding inflammatory and medullary breast cancers).
  • Scheduled to receive short-course external beam radiation therapy (i.e., 2.0-3.0 Gy for 15-20 fractions) or conventional external beam radiation therapy (i.e., 1.8-2.0 Gy for 25-40 fractions), with or without boost dose, to the whole breast.
  • Not receiving concurrent chemotherapy.
  • Subject may have had chemotherapy prior to radiation. A minimum of two weeks is required between the end of chemotherapy and start of radiation therapy.
  • No history of previous breast or chest radiation therapy.
  • Subject may or may not have had surgery (lumpectomy or mastectomy) prior to RT. (Note: Surgery is not required for eligibility).
  • Subjects may be currently prescribed hormone treatment or Herceptin therapy.
  • Subjects must be able to read, speak, and understand English language (all study forms are in English).
  • Subjects must be able to give informed consent.
  • Subjects must be willing to have photographs taken of radiation-induced skin changes in the radiation treatment area.
  • Subjects must be willing to wear Silverlon dressing and undergarment (i.e., bra) at all times, except when bathing/showering and during their radiation therapy session.
  • Subjects must be willing to complete a Silverlon Compliance Log to document the date and time that Silverlon was removed and applied each day during the study.

Exclusion criteria

  • Diagnosis of medullary or inflammatory breast cancer.
  • Diagnosis of tumors of the breast other than primary breast cancer (skin cancers, lymphomas, or metastatic cancers from other primary sites).
  • Partial breast irradiation (PBI) treatment technique is not eligible.
  • Concurrent chemotherapy.
  • Pregnant or planning to become pregnant. Pregnant females are ineligible because pregnancy is a contraindication for RT. All subjects of childbearing potential will be asked if they are pregnant or could be pregnant. The subject must respond "no" to continue with radiation and to participate in this clinical study.
  • Previous radiation to the chest or breast.
  • Radiation being given for palliative purposes.
  • Presence of unhealed surgical wounds, biopsy sites, open wounds in the breast or chest area.
  • Presence of breast infection.
  • Subjects currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225).
  • Previous diagnosis of autoimmune disease, connective tissue disease, or radiosensitivity disorder.
  • Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc).
  • Chronic skin disease of the breast, previous breast trauma or scarring of the breast
  • Subjects with known sensitivity to silver or nylon.
  • Subjects unable or unwilling to wear Silverlon dressings and undergarment (i.e., bra) at all times, except while bathing/showering and during their radiation therapy session.
  • Subjects unable to speak, read, or understand English language (all study forms are in English).

Treatment and study plan

Silverlon

Device

silver nylon dressing will be applied daily

Primary outcomes

  1. Number of Participants With an Adverse Skin Event

    Time frame: 12 weeks

Secondary outcomes

  1. Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score

    Time frame: 2 weeks

    The radiation oncologist or nurse will rate the skin reaction in the area where Silverlon dressing was applied using the RTOG scale which ranges from 0-5 with higher scores indicating worse outcome.

    Grade 0 No change; Normal Skin Grade 1 Faint erythema; dry desquamation; epilation, decreased sweating Grade 2 Tender or bright erythema; moderate edema; patchy moist desquamation only in skin folds.

    Grade 3 Confluent moist desquamation in areas other than skin folds; pitting edema Grade 4 Ulceration; hemorrhage; necrosis

  2. Mean Radiation Induced Skin Reaction Assessment Scale

    Time frame: Mid study-visit, approximately 2 weeks

    This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HPAS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

  3. Mean Radiation Induced Skin Reaction Assessment Scale

    Time frame: End of radiation therapy, approximately 4.5 weeks

    This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HAPS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

  4. Mean Radiation Induced Skin Reaction Assessment Scale

    Time frame: 2 weeks post radiation therapy, approximately 6.5 weeks

    This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HPAS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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