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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01856543
First received: May 15, 2013
Last updated: August 11, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Invasive Breast Cancer
Other: Eucerin
Other: Mometasone Furoate 0.1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • skin toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Skin toxicity assessments and assessment of patient-reported compliance 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.


Secondary Outcome Measures:
  • Patient-reported skin toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    will be measured using the Skindex-16 assessment tool. Clinician will assess the patients' Fitzpatrick Skin Category.


Enrollment: 143
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856543

Locations
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07939
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States, 10604
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Molly Olm-Shipman, RN Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01856543     History of Changes
Other Study ID Numbers: 13-069 
Study First Received: May 15, 2013
Last Updated: August 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast cancer
Status post mastectomy
plan to receive PMRT
Topical
steroid cream
emollient skin care
Eucerin
Mometasone Furoate 0.1%

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 23, 2016