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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03768492). StuddyBuddy aggregates publicly available trial information.