Phase 3
N=143
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
Invasive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01856543 ↗Enrolled (actual)
143
Serious AEs
4.2%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants With Moist Desquamation — 66.7; 43.8 % of participants w/moist desquamation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eucerin (Other); Mometasone Furoate 0.1% (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Moist Desquamation |
66.7; 43.8 | — |
| SECONDARY Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment |
8.0; 5.0; 6.0; 6.0; 2.0; 1.0 | — |
| SECONDARY Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up |
15.0; 12.0; 11.0; 11.0; 6.0; 5.0 | — |
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 from peeling, or reducing the amount of irritation the patient reports during treatment.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01856543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.