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

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ClinicalTrials.gov Identifier: NCT03768492
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Carcinoma Breast Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base. Other: Lipoderm Cream Base Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Caffeine Based Cream
caffeine based cream during and for 4 weeks following radiation
Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.
Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm

Placebo Comparator: Placebo
placebo cream during and for 4 weeks following radiation
Other: Lipoderm Cream Base
Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm




Primary Outcome Measures :
  1. Standard Toxicity Scoring [ Time Frame: 4 Years ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768492


Contacts
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Contact: Carmen A Perez 212 731 5003 Carmen.Perez@nyulangone.org

Locations
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United States, New York
New York University Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Carmen A Perez    212-731-5003    Carmen.Perez@nyulangone.org   
Principal Investigator: Naamit K Gerber, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Naamit Kurshan Gerber NYU Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03768492     History of Changes
Other Study ID Numbers: 18-00309
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Single-institution investigator initiated trial. We are not going to make our data available to others.

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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

Keywords provided by NYU Langone Health:
Masectomy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents