MediHoney for Radiation Dermatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | June 2014 |
| End Date: | December 2016 |
| Contact: | Bahiyyah Jackson, MS |
| Email: | bjackson1@umm.edu |
| Phone: | 410-328-7586 |
A Pilot Study: Topical Application of Medihoney for Management of Radiation Dermatitis
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.
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.
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 side effect is acute skin reaction, which can range from mild erythema to
confluent moist desquamation. Almost all patients receiving radiation therapy have a risk of
developing radiation dermatitis (Trueman, 2012).
When not managed appropriately, radiation dermatitis can affect patients' physical
functioning and quality of life. It can also cause pain and discomfort and may result in
infection and/or interruption of treatment (Feight et al., 2011). An important role for
oncology nurses is in educating, assessing, and monitoring patients for radiation
dermatitis. Many nursing interventions are in use, including those based on tradition,
physician preference, and published reports. In routine practice, most interventions for
radiation dermatitis are institution-specific and not reliably evidence based.
At the investigators institution, Hydrophor (Aquaphor), an ointment containing petrolatum,
mineral oil, ceresin, and lanolin alcohol is the current standard of care for preventing and
treating radiation dermatitis. Some women under treatment for breast cancer report disliking
the smell and/or texture of Hydrophor. Rarely reported side effects have included allergic
reactions, burning, stinging, and/or redness. Honey is an ancient remedy that has most
recently shown promising results in treating burns, oral infections, and promoting surgical
wound healing and palliation. The topical application of honey has been reported to be
advantageous in radiation mucositis (Biswal et al., 2003). In a continuing effort to
identify those treatment options that can make the investigators patients more comfortable
and reduce complications from radiation dermatitis, the investigators are interested in
conducting a small pilot study comparing the effectiveness of a honey-based treatment
(Medihoney) with that of the investigators current standard of care (Hydrophor).
is a widely reported side effect of radiation therapy in cancer. The most common radiation
therapy-induced side effect is acute skin reaction, which can range from mild erythema to
confluent moist desquamation. Almost all patients receiving radiation therapy have a risk of
developing radiation dermatitis (Trueman, 2012).
When not managed appropriately, radiation dermatitis can affect patients' physical
functioning and quality of life. It can also cause pain and discomfort and may result in
infection and/or interruption of treatment (Feight et al., 2011). An important role for
oncology nurses is in educating, assessing, and monitoring patients for radiation
dermatitis. Many nursing interventions are in use, including those based on tradition,
physician preference, and published reports. In routine practice, most interventions for
radiation dermatitis are institution-specific and not reliably evidence based.
At the investigators institution, Hydrophor (Aquaphor), an ointment containing petrolatum,
mineral oil, ceresin, and lanolin alcohol is the current standard of care for preventing and
treating radiation dermatitis. Some women under treatment for breast cancer report disliking
the smell and/or texture of Hydrophor. Rarely reported side effects have included allergic
reactions, burning, stinging, and/or redness. Honey is an ancient remedy that has most
recently shown promising results in treating burns, oral infections, and promoting surgical
wound healing and palliation. The topical application of honey has been reported to be
advantageous in radiation mucositis (Biswal et al., 2003). In a continuing effort to
identify those treatment options that can make the investigators patients more comfortable
and reduce complications from radiation dermatitis, the investigators are interested in
conducting a small pilot study comparing the effectiveness of a honey-based treatment
(Medihoney) with that of the investigators current standard of care (Hydrophor).
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.
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