Clinical trial · Interventional

Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

NCT00438659CI-TRIAL-00023307completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis. PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Dermatologic Complications	—	UNRESOLVED	—
Radiation Toxicity	—	UNRESOLVED	—
Skin Reactions Secondary to Radiation Therapy	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
mometasone furoate	Drug	—	UNRESOLVED
placebo	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Mometasone
description
Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
interventionNames
1. Drug: mometasone furoate
type
PLACEBO_COMPARATOR
label
Placebo
description
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
interventionNames
1. Other: placebo

Primary outcomes (1)

measure
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ
* Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:

  * Whole breast (as part of breast-conservation therapy)
  * Chest wall (as part of post-mastectomy irradiation)

    * Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed
* Must meet the following criteria for planned radiotherapy:

  * Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
  * No planned split-course radiotherapy
  * No partial breast treatment, defined as treatment of \< 75% of the breast parenchyma
  * Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed
* Must be entered on study within 7 days prior to beginning radiotherapy

  * Must start study drug prior to receiving the third radiotherapy fraction
* No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
* No bilateral breast cancer treatment
* No inflammatory carcinoma of the breast
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to complete questionnaires independently or with assistance
* No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy to the planned radiotherapy treatment area
* No concurrent or planned leukotriene inhibitors, including the following:

  * Zafirleukast
  * Monteleukast
  * Zileuton
* No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:

  * Cortaid®
  * Cortizone 10®
  * Tucks®
  * Preparation H®
* No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment

References

Publications (3)

BACKGROUNDAtherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16. PMID 21922203
RESULTMiller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA. Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1460-6. doi: 10.1016/j.ijrobp.2010.01.031. Epub 2010 Aug 26. PMID 20800381
RESULTNeben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC. Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a Phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):397-402. doi: 10.1016/j.ijrobp.2010.05.065. Epub 2010 Oct 1. PMID 20888137

Registry

Dates and enrollment

Start: Aug 1, 2007
Primary completion: Jan 1, 2010
Completion: Jun 1, 2014
First posted: Feb 22, 2007
Last update posted: Aug 1, 2016
Results first posted: Feb 12, 2015
Enrollment: 176 (actual)
Lead sponsor: North Central Cancer Treatment Group NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: dermatologic complications, skin reactions secondary to radiation therapy, radiation toxicity, breast cancer in situ, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer, ductal breast carcinoma in situ, stage IV breast cancer

Data updated 22 days agoSource updated Aug 1, 2016source: clinicaltrials

Locations

Locations by country (189)

Country	Sites	Recruiting
United States