Radiation Dermatitis: A phase 1 randomized double blinded placebo controlled study of the safety and efficacy of a caffeine-based antifibrosis cream in patients with breast cancer undergoing radiation therapy (ReDCoAT Study) | NYU Langone Health

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Radiation Dermatitis: A phase 1 randomized double blinded placebo controlled study of the safety and efficacy of a caffeine-based antifibrosis cream in patients with breast cancer undergoing radiation therapy (ReDCoAT Study)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Radiation Dermatitis / Breast Cancer
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted) 2) Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the treating radiation oncologist. 3) Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.

You may not be eligible for this study if the following are true:

1) Patient with skin changes or inflammatory carcinoma at presentation (cT4b-d) 2) Patient has unhealed wound in the radiation field 3) Patient has allergy to Caffeine 4) Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development 5) Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab)