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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00481884 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Radiation Dermatitis |
Other: RadiaPlexRx Gel Other: Aquaphor Gel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients |
| Estimated Enrollment: | 92 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
RadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process.
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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.
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2: Active Comparator
Aquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process.
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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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Show Detailed Description
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Tse-Kuan Yu, MD, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Tse-Kuan Yu, MD PhD/Asst. Professor ) |
| Study ID Numbers: | 2006-0827 |
| Study First Received: | May 31, 2007 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00481884 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Radiation Dermatitis RadiaPlexRx Gel Aquaphor |
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Skin Diseases Wounds and Injuries Disorders of Environmental Origin Radiodermatitis |
Breast Neoplasms Radiation Injuries Breast Diseases Dermatitis |
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Neoplasms Neoplasms by Site Skin Diseases Wounds and Injuries Disorders of Environmental Origin |
Radiodermatitis Breast Neoplasms Radiation Injuries Breast Diseases Dermatitis |