Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients

Completed · Phase 3

Conditions studied: Radiation Dermatitis

In brief

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.

Key facts

Study ID

NCT00481884

Run by

M.D. Anderson Cancer Center

People needed

80

Starts

2007-05-01

Expected to finish

2012-01-01

Last updated by the study team

2016-05-02

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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