Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00481884
First received: May 31, 2007
Last updated: January 18, 2012
Last verified: January 2012
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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 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Petrolatum
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 80 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
- Patient has breast conserving surgery (lumpectomy) for breast cancer with negative surgical margin
- Stage Tis,0-3 N0-2 M0
- Patient will receive irradiation of whole breast. An additional field to treat the supraclavicular / axillary apex lymphatics is allowed, but a separate field to treat the internal mammary chain nodes is not allowed
- The breast will receive radiation dose greater than or equal to 50 Gy, with or without a boost field to give additional dose to the tumor bed
- Patient wears bras with cup size larger than A
- Patient signs informed consent
Exclusion Criteria:
- Breast cancer treatment with mastectomy
- Stage T4 breast cancer
- Patient will require the use of tissue-equivalent bolus during radiation treatment or double treatment of junctions of radiation treatment fields
- Patient will require treatment to the internal mammary chain lymph node bed using a separate radiation electron field
- Patient is planned for partial-breast irradiation or Mammo-site treatment.
- Patient has unhealed wound or rash in the radiation field
- Patient has allergy to RadiaPlexRx or aloe vera
- Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
- Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Herceptin® [Trastuzumab])
- Planned accelerated fractionation.
- Planned radiation therapy to the bilateral breasts
- Planned breast irradiation in the prone position
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481884
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Thomas Buchholz, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00481884 History of Changes |
| Other Study ID Numbers: | 2006-0827 |
| Study First Received: | May 31, 2007 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Radiation Dermatitis RadiaPlexRx Gel Aquaphor |
Additional relevant MeSH terms:
|
Breast Neoplasms Dermatitis Radiodermatitis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Radiation Injuries Wounds and Injuries Petrolatum Emollients Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013