Clinical trial NCT01856543: Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
Official title: Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation:A Randomized Trial, Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Breast Cancer
Keywords: Breast cancer
Status post mastectomy
plan to receive PMRT
Topical
steroid cream
emollient skin care
Eucerin
Mometasone Furoate 0.1%
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants With Moist Desquamation
timeFrame: 2 years
Secondary outcomes:
measure: Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment
timeFrame: 5 weeks and Baseline
measure: Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up
timeFrame: 2 weeks after end of Radiation Therapy
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Molly Olm-Shipman, RN
role: PRINCIPAL_INVESTIGATOR
References: