Status:
ACTIVE_NOT_RECRUITING
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Lead Sponsor:
NYU Langone Health
Conditions:
Carcinoma Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-mastect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03768492
Start Date
June 29 2020
End Date
December 1 2027
Last Update
July 30 2025
Active Locations (1)
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1
New York University Medical Center
New York, New York, United States, 10016