Status:
COMPLETED
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Invasive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01856543
Start Date
May 1 2013
End Date
January 1 2017
Last Update
October 3 2019
Active Locations (6)
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1
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07939
2
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States, 11725
3
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065