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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00438659
First received: February 20, 2007
Last updated: February 11, 2015
Last verified: February 2015
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Dermatologic Complications
Radiation Toxicity
Skin Reactions Secondary to Radiation Therapy
Interventions: Drug: mometasone furoate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total of 176 patients were enrolled on this trial between 9/21/07 and 12/07/2007. There were 7 cancels (5 in Arm A and 2 in Arm B) and 3 patients discontinued treatment (1 in Arm A and 2 in Arm B). In total 84 in Arm A and 82 in Arm B were evaluable for the primary endpoint.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mometasone Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
Placebo Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Participant Flow:   Overall Study
    Mometasone     Placebo  
STARTED     90     86  
COMPLETED     84     82  
NOT COMPLETED     6     4  
Discontinued Mometasone/Placebo                 1                 2  
Cancel                 5                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All (169) eligible patients are included in the baseline analysis. There were 5 cancels in Arm I and 2 in Arm II.

Reporting Groups
  Description
Mometasone Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
Placebo Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
Total Total of all reporting groups

Baseline Measures
    Mometasone     Placebo     Total  
Number of Participants  
[units: participants]
  85     84     169  
Age  
[units: years]
Median (Full Range)
  60    (35 to 89)     57    (27 to 85)     59    (27 to 89)  
Gender  
[units: participants]
     
Female     85     84     169  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     85     84     169  



  Outcome Measures
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1.  Primary:   Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.   [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]

2.  Secondary:   Incidence of Severe ( Grade >=3) Radiation Dermatitis   [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]

3.  Secondary:   Skin Toxicity as Measured by the Skin Toxicity Assessment Tool   [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]

4.  Secondary:   Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).   [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]

5.  Secondary:   Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.   [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]

6.  Secondary:   Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)   [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]

7.  Secondary:   QOL Domains as Measured by LASA   [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]

8.  Secondary:   Adverse Events Assessed Clinically by NCI CTCAE v3.0   [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]

9.  Secondary:   Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).   [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert C. Miller, M.D.
Organization: Mayo Clinic
e-mail: miller.robert@mayo.edu


Publications of Results:
Other Publications:

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT00438659     History of Changes
Other Study ID Numbers: NCCTG-N06C4, NCI-2012-02708, CDR0000530309
Study First Received: February 20, 2007
Results First Received: June 12, 2014
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration