This phase II trial studies the side effects of topical caffeine compound and to see how well it works in reducing the complications in patients with stage 0-III breast cancer who are undergoing radiation therapy. Radiation therapy (RT) is a key component of treatment for some breast cancer patients. Radiation-induced fibrosis (RIF) of the skin and subcutaneous tissues is a potential complication that can occur months after RT and progress over several years. RIF is a common adverse outcome in breast cancer patients. The skin and superficial tissues receive almost full dose of radiation and are at risk for RIF. Applying topical caffeine compound to the skin during the RT may help to reduce the risk for RIF.
Additional locations may be listed on ClinicalTrials.gov for NCT03768492.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To compare the cumulative rates of reconstructive complications requiring rehospitalization or reoperation by 2 years post radiation including reconstructive failure with or without reconstruction.
II. To compare the proportions of patients with >= grade 2 acute radiation dermatitis within the first 90 days from start of radiation therapy with caffeine cream to placebo cream.
SECONDARY OBJECTIVES:
I. To evaluate the effect of the topical caffeine compound on reconstructive complications not included in the primary objective compared to placebo cream.
II. To evaluate the effect of the topical caffeine compound on patient-rated and clinician rated cosmesis compared to placebo cream.
III. To evaluate the effect of the topical caffeine compound on disease outcomes and survival compared to placebo cream.
IV. To evaluate the effect of the topical caffeine compound on skin thickness, fibrosis, angiogenesis, and scarring on tissue removed after completion of radiation compared to placebo cream.
V. To evaluate the proportion of patients with >= grade 2 late radiation fibrosis in patients who receive the topical caffeine compound and in patients who receive the placebo cream.
EXPLORATORY OBJECTIVES:
I. To evaluate shear wave elastography soft tissue stiffness and thickness measurements in patients who receive the topical caffeine compound and in patients who receive placebo cream.
II. To evaluate the change in shear wave elastography soft tissue stiffness and thickness measurements from baseline to time of implant exchange and two years after RT completion of radiation in patients who receive the topical caffeine compound and in patients who receive the placebo cream.
III. To evaluate the association of shear wave elastography soft tissue stiffness and thickness measurements and epidermal thickness and fat layer thickness on hematoxylin and eosin (H&E) from tissue obtained at time of implant exchange in patients who receive the topical caffeine compound and in patients who receive the placebo cream.
IV. To evaluate the association of shear wave elastography soft tissue stiffness and thickness measurements and radiation fibrosis at 2 years after RT completion in patients who receive the topical caffeine compound and in patients who receive the placebo cream.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients apply topical caffeine-based cream over the irradiated chest wall twice daily during radiation until the removal of tissue expanders.
GROUP II: Patients apply placebo (Lipoderm cream base) over the irradiated chest wall twice daily during radiation until the removal of tissue expanders.
After completion of radiation treatment, patients are followed up at 4, 8, 12, and 16 weeks, 6 months, and then yearly for up to 4 years.
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorNaamit Kurshan Gerber
