Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02234479
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2014-09-02
Brief Title:
MediHoney for Radiation Dermatitis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Pilot Study Topical Application of Medihoney for Management of Radiation Dermatitis
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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 andor texture of Hydrophor Rarely reported side effects have included allergic reactions burning stinging andor 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
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 andor 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 andor texture of Hydrophor Rarely reported side effects have included allergic reactions burning stinging andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None