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

NCT03768492 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 18-00309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma Breast

Keywords

Masectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Caffeine Based Cream

EXPERIMENTAL

caffeine based cream during and for 4 weeks following radiation

Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.

Placebo

PLACEBO COMPARATOR

placebo cream during and for 4 weeks following radiation

Other: Lipoderm Cream Base

Interventions

Caffeine anhydrous 5% added to Lipoderm Cream Base. DRUG

Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm

Caffeine Based Cream

Lipoderm Cream Base OTHER

Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Naamit Kurshan Gerber

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: June 29, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)