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

Phase 2

Active, not recruiting

• Conditions: Carcinoma Breast
• Interventions: Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.; Other: Lipoderm Cream Base

• Registration Number: NCT03768492
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2019-12-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeine Based Cream	Caffeine anhydrous 5% added to Lipoderm Cream Base.	caffeine based cream during and for 4 weeks following radiation
Placebo	Lipoderm Cream Base	placebo cream during and for 4 weeks following radiation

Primary Outcome Measures

Name	Time	Method
Standard Toxicity Scoring	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).

Trial Locations

Locations (1)

New York University Medical Center; 🇺🇸 New York, New York, United States