Status:
COMPLETED
MediHoney for Radiation Dermatitis
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Breast Cancer
Radiation Dermatitis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the ou...
Detailed Description
Background: Radiation dermatitis, also known as radiodermatitis or radiation skin reaction, is a widely reported side effect of radiation therapy in cancer. The most common radiation therapy-induced s...
Eligibility Criteria
Inclusion
- Breast cancer treated with either lumpectomy or mastectomy (with or without reconstruction).
- The patient must be female.
- Radiation therapy planned to whole breast/chestwall area (can include lymph node radiation; conventional 3D radiation, IMRT/IGRT, and hypofractionation are all allowed).
- Age ≥ 18 years old.
Exclusion
- Previous radiation therapy to chest area that would result in overlapping radiation fields.
- Wound care issues.
- Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy (concurrent Herceptin and/or tamoxifen/aromatase inhibitors and RT is allowed).
- Patients receiving HDR (savi or mammosite) brachytherapy treatments.
- Patients with an allergy and/or sensitivity to Hydrophor, honey, and/or Medihoney.
- Immunocompromised status.
- Age \< 18 years old.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02234479
Start Date
June 1 2014
End Date
December 1 2014
Last Update
March 18 2020
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201