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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

NCT00902668

Breast Cancer Radiation Toxicity

TERMINATED PHASE2

Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer

NCT02486796

Quality of Life

TERMINATED PHASE1/PHASE2

Study of Bimatoprost Gel on Eyelash Growth

NCT01200251

Madarosis Hypotrichosis

COMPLETED PHASE3

Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast

NCT03063619

Mammographically Dense Breast

COMPLETED PHASE2

Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

NCT02314156

BRCA1 Mutation Carrier BRCA2 Mutation Carrier Ductal Breast Carcinoma In Situ +6 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Eucerin

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Mometasone Furoate 0.1%

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eucerin

Intervention Type OTHER

Mometasone Furoate 0.1%

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No