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Active Not Recruiting
NCT03768492
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Conditions: Carcinoma Breast
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: NYU Langone Health
Location: New York University Medical Center New York New York
Summary
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.
Eligibility Criteria
Inclusion Criteria:
* Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
* Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.
* Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed.
Exclusion Criteria:
* Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d)
* unhealed wound in the radiation field
* Patient has allergy to Caffeine
* 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 Trastuzumab)
* Planned accelerated or hypofractionated fractionation.
* Previous radiation to the ipsilateral breast or chest wall or thoracic region.
* Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint.
* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
Source: ClinicalTrials.gov (NCT03768492). StuddyBuddy aggregates publicly available trial information.