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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

Conditions
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Carcinoma Breast

Intervention / Treatment
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* Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.
* Other: Lipoderm Cream Base


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine Based Cream<br>caffeine based cream during and for 4 weeks following radiation | Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.<br>* Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm<br>|
| Placebo Comparator: Placebo<br>placebo cream during and for 4 weeks following radiation | Other: Lipoderm Cream Base<br>* Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Toxicity Scoring | The US National Cancer Institute developed the Common Terminology Criteria for Adverse Events (CTCAE), which was formerly called the Common Toxicity Criteria (CTC), which is a standardized classification of adverse effects in cancer therapy. The current version 5.0 was released in 2017. The criteria uses a grading system of 1 to 5 (e.g. Grade 1 = mild and Grade 5 = death related to AE). | 4 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Masectomy