Back to resultsStudy of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy (ReDCoAT)
Primary Purpose
Carcinoma Breast
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Caffeine anhydrous 5% added to Lipoderm Cream Base.
Lipoderm Cream Base
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma Breast focused on measuring Masectomy
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.
Sites / Locations
- New York University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Caffeine Based Cream
Placebo
Arm Description
caffeine based cream during and for 4 weeks following radiation
placebo cream during and for 4 weeks following radiation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03768492
Brief Title
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Acronym
ReDCoAT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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-mastectomy radiation therapy when compared to a placebo cream.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Breast
Keywords
Masectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caffeine Based Cream
Arm Type
Experimental
Arm Description
caffeine based cream during and for 4 weeks following radiation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo cream during and for 4 weeks following radiation
Intervention Type
Drug
Intervention Name(s)
Caffeine anhydrous 5% added to Lipoderm Cream Base.
Intervention Description
Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
Intervention Type
Other
Intervention Name(s)
Lipoderm Cream Base
Intervention Description
Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
Primary Outcome Measure Information:
Title
Standard Toxicity Scoring
Description
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).
Time Frame
4 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naamit Kurshan Gerber
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Single-institution investigator initiated trial. We are not going to make our data available to others.
Learn more about this trial
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
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