Radiation Dermatitis Research Study
Clinic: John B. Amos Cancer Center
Location: Columbus, GA
Radiation therapy is one of the most common treatments for cancer. Although it is considered an effective treatment for breast cancer, it is also known for causing changes in the skin tissue within the irradiated area, including damage to the normal cells and inflammatory reaction in the different skin layers. Radiation- induced dermatitis is a common side effect that can develop within hours after radiation exposure and typically lasts for 30 to 90 days. Symptoms usually seen are mild transient erythema (reddening of skin) sunburn-like reaction, edema (swelling), dryness, burning, itching, and tenderness, dry desquamation, (characterized by dry and scaly skin), and moist desquamation (characterized by destruction and sloughing of skin layers, pain, and fluid drainage). In some patients this may lead to ulceration of the skin. Currently there is no FDA-approved drug for the prevention or treatment of radiation-induced dermatitis. It is therefore important to identify possible effective treatments for this condition.
Qualifications
- >/=18 year old female
- Diagnosed with non-metastatic breast cancer.
- Completed fractionated radiation therapy (either conventional or hypofractionated) for breast cancer >3 days and ≤14 days prior to first dose of study drug
- Developed a grade 2 radiation dermatitis
- Have a score of at least 6 points in the DLQI (QoL questionnaire)
Compensation
Stipend of $50 for travel and other expenses (such as parking, mileage, meal, accommodation) incurred in connection with study visits will be paid following each completed study visit.
Study Duration
The duration of the study is approximately 13 weeks, including 7 days screening period, 4 weeks of daily treatment and 2 follow up visits (one and two months after last study drug administration).
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