NCT01856543

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

May 15, 2013

Results QC Date

December 12, 2017

Last Update Submit

September 9, 2019

Conditions

Invasive Breast Cancer

Keywords

Breast cancerStatus post mastectomyplan to receive PMRTTopicalsteroid creamemollient skin careEucerinMometasone Furoate 0.1%

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment

    5 weeks and Baseline

  • Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up

    2 weeks after end of Radiation Therapy

Study Arms (2)

Eucerin

PLACEBO COMPARATOR

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

Mometasone Furoate 0.1%

EXPERIMENTAL

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%

Interventions

EucerinOTHER
Eucerin
Mometasone Furoate 0.1%OTHER
Mometasone Furoate 0.1%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07939, United States

Location

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eucerin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Daphna Gelblum
Organization
Memorial Sloan Kettering Cancer Center
gelblumd@mskcc.org
914-367-7273

Study Officials

  • Molly Olm-Shipman, RN

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 17, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 3, 2019

Results First Posted

October 3, 2019

Record last verified: 2018-08

Locations

US(6)