N/A
N=34
MediHoney for Radiation Dermatitis
Breast Cancer · Radiation Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02234479 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy — 15; 15; 15; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrophor (Group A) (Biological); MediHoney (Group B) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy |
15; 15; 15; 15 | — |
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 outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02234479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.