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

NCT ID: NCT03768492

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caffeine Based Cream

caffeine based cream during and for 4 weeks following radiation

Group Type: EXPERIMENTAL

Caffeine anhydrous 5% added to Lipoderm Cream Base.

Intervention Type: DRUG

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

Placebo

placebo cream during and for 4 weeks following radiation

Group Type: PLACEBO_COMPARATOR

Lipoderm Cream Base

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

Lipoderm Cream Base

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naamit Kurshan Gerber

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

New York University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

18-00309

Identifier Type: -

Identifier Source: org_study_id