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

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

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.

Study Overview

• Status: Completed
• Conditions: Invasive Breast Cancer
• Intervention / Treatment: Other: Eucerin; Other: Mometasone Furoate 0.1%

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07939
      • Memorial Sloan Kettering Cancer Center at Basking Ridge
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering West Harrison
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Cancer Center at Mercy Medical Center
    • Sleepy Hollow, New York, United States, 10591
      • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Eucerin; Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.	Other: Eucerin
EXPERIMENTAL: Mometasone Furoate 0.1%; Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Patients should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.	Other: Mometasone Furoate 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Molly Olm-Shipman, RN, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2013
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (ESTIMATE): May 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Breast cancer; Topical; Status post mastectomy; plan to receive PMRT; steroid cream; emollient skin care; Eucerin; Mometasone Furoate 0.1%
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: 13-069