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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Invasive Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Age ≥18 years

- Stage 1-3 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 distant metastasis or locally recurrent breast cancer

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

skin toxicity

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Molly Olm-Shipman, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

13-069

NCT ID:

NCT01856543

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Invasive Breast Cancer
  • Breast cancer
  • Status post mastectomy
  • plan to receive PMRT
  • Topical
  • steroid cream
  • emollient skin care
  • Eucerin
  • Mometasone Furoate 0.1%
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725