Breast Cancer Clinical Trial

Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT03768492

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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New York University Medical Center
New York New York, 10016, United States More Info
Naamit K Gerber, MD
Contact
646-596-8528
[email protected]
Naamit K Gerber, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT03768492

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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