Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481884
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2007-05-31
Brief Title:
Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-01
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:
Primary Objective
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
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
Detailed Description:
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
Clinic Visits
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
End-of-Study
-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
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
Clinic Visits
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
End-of-Study
-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
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