Mometasone Furoate in Preventing Radiation Dermatitis in... | NCT00438659

ID	Type	Description	Link
NCI-2012-02708	Registry Identifier	CTRP (Clinical Trials Reporting System)
CDR0000530309	Registry Identifier	PDQ (Physician Data Query)

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

OBJECTIVES:

Primary

Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Secondary

Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
Compare the time to onset and duration of severe radiation dermatitis in these patients.
Assess skin toxicity and quality of life of these patients.
Assess the adverse event profile of mometasone furoate in these patients.
Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast [post-lumpectomy] vs chest wall [post-mastectomy]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs > 55 Gy). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.

Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.

After completion of radiotherapy, patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Label	Type	Description	Intervention Names
Mometasone	Experimental	Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.	Drug: mometasone furoate
Placebo	Placebo Comparator	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.	Other: placebo

Name	Type	Description	Arm Group Labels	Other Names
mometasone furoate	Drug	Applied to treatment area	Mometasone
placebo

Measure	Description	Time Frame
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.	Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).	During Radiation Treatment, up to a maximum of 9 weeks.

Measure	Description	Time Frame
Incidence of Severe ( Grade >=3) Radiation Dermatitis	To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.	During Radiation Treatment, up to a maximum of 9 weeks.
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Robert C. Miller, MD	Mayo Clinic	Study Chair
Patricia Griffin, MD	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Study Chair
James A. Martenson, MD	Mayo Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Rush-Copley Cancer Care Center		Aurora	Illinois	60507	United States
St. Joseph Medical Center

PubMed Identifier	Type	Citation	Retractions
21922203	Background	Atherton 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.
20800381	Result

ID	Title	Description
FG000	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.
FG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.

Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).

Posted

Mean

Full Range

Grade

During Radiation Treatment, up to a maximum of 9 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG00084 OG00182

Title

Denominators

Categories

Title	Measurements
	OG0001.2(0.0 to 3.0) OG0011.3(0.0 to 3.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.18													No	Superiority or Other

Secondary

Incidence of Severe ( Grade >=3) Radiation Dermatitis

To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.

Posted

Number

Paticipants

During Radiation Treatment, up to a maximum of 9 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG000

Secondary

Skin Toxicity as Measured by the Skin Toxicity Assessment Tool

Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.

Posted

Mean

Standard Deviation

Score on a 0 to 5 scale

During Radiation Treatment, up to a maximum of 9 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG000

Secondary

Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).

Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).

Posted

Mean

Standard Deviation

score on a 0-6 scale

During Radiation Treatment, up to a maximum of 11 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG000

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.

To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.

This analysis was not completed due to too little incidence of the dermatitis.

Posted

During Radiation Treatment, up to a maximum of 9 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG000

Secondary

Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)

Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).

Patients who completed at least 1 assessment were evaluable for this secondary end point.

Posted

Mean

Standard Deviation

units on a scale

During Radiation Treatment, up to a maximum of 11 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.

Units	Counts
Participants	OG000

Secondary

QOL Domains as Measured by LASA

Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.

Patients who completed at least 1 assessment were evaluable for this secondary end point.

Posted

Mean

Standard Deviation

units on a scale

During Radiation Treatment, up to a maximum of 11 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.

Units	Counts
Participants	OG000

Secondary

Adverse Events Assessed Clinically by NCI CTCAE v3.0

Posted

Number

participants

During Radiation Treatment, up to a maximum of 9 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Units	Counts
Participants	OG000

Secondary

Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).

Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)

Posted

Mean

Standard Deviation

units on a scale

During Radiation Treatment, up to a maximum of 11 weeks.

ID	Title	Description
OG000	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.
OG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected84 at risk EG0011 events1 affected82 at risk
Fatigue	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected84 at risk EG0011 events1 affected82 at risk
Pain	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected84 at risk EG0012 events1 affected82 at risk
Skin infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected84 at risk EG0011 events1 affected82 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG000235 events64 affected84 at risk EG001263 events69 affected82 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG00083 events38 affected84 at risk EG00181 events39 affected82 at risk
Joint pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected84 at risk EG0010 events0 affected82 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected84 at risk EG0011 events1 affected82 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected84 at risk EG0012 events1 affected82 at risk
Atrophy skin	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected84 at risk EG0016 events2 affected82 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG000137 events51 affected84 at risk EG001214 events69 affected82 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00042 events19 affected84 at risk EG00148 events25 affected82 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00014 events6 affected84 at risk EG00121 events9 affected82 at risk
Skin striae	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00012 events3 affected84 at risk EG00124 events6 affected82 at risk

ID	Term
D001943	Breast Neoplasms
D011832	Radiation Injuries
D000071960	Breast Carcinoma In Situ
D018567	Breast Neoplasms, Male
D002285	Carcinoma, Intraductal, Noninfiltrating

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D014947	Wounds and Injuries
D002278	Carcinoma in Situ
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D000230	Adenocarcinoma
D018299	Neoplasms, Ductal, Lobular, and Medullary

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	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.
BG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			0	84	75	84
EG001	Placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.			0	82	81	82