Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation

Completed · Phase 3

Conditions studied: Invasive Breast Cancer

In brief

The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment.

Key facts

Study ID

NCT01856543

Run by

Memorial Sloan Kettering Cancer Center

People needed

143

Starts

2013-05-01

Expected to finish

2017-01-01

Last updated by the study team

2019-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC
• Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT
• ECOG Performance Status of 0 or 1

You may not qualify if…

• Male
• Patients with clinical evidence of gross disease
• Patients who are pregnant or breastfeeding
• Prior radiation therapy to the ipsilateral chest wall or thorax
• Patients requiring a chest wall boost
• Concurrent chemotherapy (biologic agents are allowed)
• Psychiatric illness that would prevent the patient from giving informed consent
• Inability or unwillingness to comply with skin care instructions and follow-up
• Allergy to either Eucerin or MF
• Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT
• Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
• Treatment with palliative or pre-operative radiation

Where it is running

• Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Commack — Commack, New York, United States
• Memorial Sloan Kettering West Harrison — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States
• Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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