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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01856543
First Posted: May 17, 2013
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
May 15, 2013
May 17, 2013
January 30, 2017
May 2013
January 2017   (Final data collection date for primary outcome measure)
skin toxicity [ Time Frame: 2 years ]
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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 2 weeks +/- 2 business 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 2 weeks +/- 2 business 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.
 
Completed
143
January 2017
January 2017   (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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01856543
13-069
Not Provided
Not Provided
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
January 2017

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