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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00481884 |
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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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Skin Diseases Wounds and Injuries Disorders of Environmental Origin Radiodermatitis |
Breast Neoplasms Radiation Injuries Breast Diseases Dermatitis |
Neoplasms Neoplasms by Site Skin Diseases Wounds and Injuries Disorders of Environmental Origin |
Radiodermatitis Breast Neoplasms Radiation Injuries Breast Diseases Dermatitis |