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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01856543
First received: May 15, 2013
Last updated: July 2, 2014
Last verified: July 2014

May 15, 2013
July 2, 2014
May 2013
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01856543 on ClinicalTrials.gov Archive Site
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.
Patient-reported skin toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
will be measured using the Skindex-16 assessment tool. Patients will report Fitzpatrick Skin Category at the time of the History and Physical.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Invasive Breast Cancer
  • Other: Eucerin
  • Other: Mometasone Furoate 0.1%
  • 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 10-14 days following the completion of RT.
    Intervention: 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 10-14 days following the completion of RT.
    Intervention: Other: Mometasone Furoate 0.1%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
143
May 2016
May 2016   (final data collection date for primary outcome measure)

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 simulation
  • 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 non-standard, inverse-planned Intensity Modulated Radiation Therapy (IMRT), palliative or pre-operative radiation
Both
18 Years and older
No
Contact: Molly Olm-Shipman, RN 212-639-8686
Contact: Alice Ho, MD 212-639-6773
United States
 
NCT01856543
13-069
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Molly Olm-Shipman, RN Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP