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

Invasive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856543
• Other study ID #: 13-069
• Status: Completed
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Intervention

Other:
• Eucerin

• Mometasone Furoate 0.1%

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Moist Desquamation	Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.	2 years
Secondary	Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment	The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.	5 weeks and Baseline
Secondary	Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up	The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.	2 weeks after end of Radiation Therapy

External Links

•   Memorial Sloan Kettering Cancer Center