Breast CancerNCT02234479
MediHoney for Radiation Dermatitis
A study testing Hydrophor (Group A) and MediHoney (Group B) in people with Breast Cancer and Radiation Dermatitis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- What is being tested?
- Hydrophor (Group A) and MediHoney (Group B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 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).
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- Hydrophor (Group A), MediHoney (Group B)
- Keywords
- Breast Cancer, Radiation Dermatitis
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophor (Group A)Biological
- Rehydrates dry, chapped or chafed skin
- May be used alone as a skin lubricant or protectant
MediHoney (Group B)Biological
It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:
- Maintain a balanced environment for healing.
- Aids in reducing dermatitis.
- Reduce affected area pH.2-3
| Study group | Role | What they receive |
|---|---|---|
| Hydrophor (Group A) | Active comparator | Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area. Receives: Biological: Hydrophor (Group A) |
| MediHoney (Group B) | Experimental | Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area. Receives: Biological: MediHoney (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Elizabeth Nichols, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234479
- Sponsor's protocol ID
- HP-00058645
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2014
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Topical Application of Medihoney for Management of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT02234479
- Acronym / sponsor ID
- HP-00058645
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- Breast Cancer, Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophor (Group A) | Active comparator | Biological: Hydrophor (Group A)Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area. |
| MediHoney (Group B) | Experimental | Biological: MediHoney (Group B)Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrophor (Group A)* Rehydrates dry, chapped or chafed skin * May be used alone as a skin lubricant or protectant | Biological | Hydrophor (Group A) |
| MediHoney (Group B)It helps the body's natural healing processes in three key ways which have been shown to have healing benefits: * Maintain a balanced environment for healing. * Aids in reducing dermatitis. * Reduce affected area pH.2-3 | Biological | MediHoney (Group B) |
Primary outcome
Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy
Time frame: 12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Nichols, MD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrophor (Group A) and MediHoney (Group B) in people with Breast Cancer and Radiation Dermatitis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.