Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation when compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care.
Other: RadiaPlexRx Gel
Other: Aquaphor Gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients|
- Number of Patients using RadiaPlexRx Hydrogel that developed grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: RadiaPlexRx Gel
RadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process.
Other: RadiaPlexRx Gel
RadiaPlexRx Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply RadiaPlexRx gel topically 3 Times Daily to one half of the irradiated breast skin and the control, Aquaphor gel, to the other half of irradiated breast skin. This is determined through randomization process.
Active Comparator: Aquaphor Gel
Aquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process.
Other: Aquaphor Gel
Aquaphor Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply Aquaphor gel topically 3 Times Daily to one half of the irradiated breast skin and the experimental, RadiaPlexRx gel, to the other half of irradiated breast skin. This is determined through randomization process.
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The Study Gels:
RadiaPlexRx (requires a prescription) and Aquaphor (over-the-counter) are both gels that are designed to treat irradiated (received radiation) breast skin.
These 2 gels contain different ingredients that may make one gel better than the other to treat irradiated breast skin. RadiaPlexRx contains hyaluronic acid (an ingredient found naturally in skin), aloe vera, and other ingredients that help the skin heal. Aquaphor is made of mostly petroleum that helps protect the skin.
Application of Study Gels:
If you decide to participate in this study, the following steps will be taken:
- You will be given detailed instructions on how to apply both of the gels. You should not apply other gels or lotions on the areas of skin where you will be instructed to apply the study gels, unless you are instructed to do so by the treating doctor.
- You will receive a supply of both gels (in tubes) with enough to last for the length of your treatment. You will know which gel is which, but each gel will be labeled with "outer" or "inner" so that you will know which gel to use on which side. You should not tell your treating doctor which side of the breast skin is being treated with which gel so that a fair comparison of the gels can be made.
- You will apply 1 gel to the outer side of the irradiated breast skin and the other gel to the inner side of the irradiated breast skin.
- If you experience any kind of allergic reaction (such as a rash) to the study gels, you should notify the study doctor or study staff immediately.
Schedule for Study Gels:
You will need to follow the schedule for applying the gels as follows:
- You will need to apply both gels starting 1 day before the start of radiation treatments.
- You will then need to apply both gels for 6 weeks during radiation treatment.
- During the study period (1 day before the start of radiation treatment, during 6 weeks of radiation treatment), you will need to apply both gels 3 times (in the morning, afternoon, and evening just before going to sleep) each day at home.
- During the days that you receive radiation treatment, you will be asked to apply the gels immediately after you receive your radiation treatment. This will count as 1 of the 3 daily gel applications.
You will have the following tests done during your clinic visits:
- Three (3) sets of photos of your breast skin will be taken (before radiation starts and during Weeks 3 and 6 of radiation therapy treatment).
- During Weeks 1 through 6, you will go to the clinic to have your skin checked by your treating physician to learn the effects of each gel on your symptoms. .
- You will need to return any empty tubes of study gel so that new tubes can be given if you will need more.
Length of Study:
If the treating doctor sees that the irradiated breast skin reacts poorly (does not improve or gets worse) or you experience any intolerable side effects, you will be taken off this study. Otherwise, the total time on this study is about 6 weeks.
-During your last week of radiation therapy treatment you will be asked to fill out a questionnaire about how you felt about each gel.
This is an investigational study. RadiaPlexRx and Aquaphor are both FDA approved and commercially available. Up to 92 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481884
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Buchholz, MD||M.D. Anderson Cancer Center|