Trial Outcomes & Findings for 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 (NCT NCT00438659)
NCT ID: NCT00438659
Last Updated: 2016-08-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
176 participants
Primary outcome timeframe
During Radiation Treatment, up to a maximum of 9 weeks.
Results posted on
2016-08-01
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
86
|
|
Overall Study
COMPLETED
|
84
|
82
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Discontinued Mometasone/Placebo
|
1
|
2
|
|
Overall Study
Cancel
|
5
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Mometasone
n=85 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
FULL_RANGE 14.63 • n=5 Participants
|
57 years
FULL_RANGE 11.8 • n=7 Participants
|
59 years
FULL_RANGE 13.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
84 participants
n=7 Participants
|
169 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.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).
Outcome measures
| Measure |
Mometasone
n=84 Participants
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
n=82 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
|
1.2 Grade
Interval 0.0 to 3.0
|
1.3 Grade
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.
Outcome measures
| Measure |
Mometasone
n=84 Participants
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
n=82 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Incidence of Severe ( Grade >=3) Radiation Dermatitis
Did not experience grade >=3 radiation dermatitis
|
80 Paticipants
|
78 Paticipants
|
|
Incidence of Severe ( Grade >=3) Radiation Dermatitis
Experience grade >=3 radiation dermatitis
|
4 Paticipants
|
4 Paticipants
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.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.
Outcome measures
| Measure |
Mometasone
n=83 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
STAT: Discomfort/Burning
|
1.5 Score on a 0 to 5 scale
Standard Deviation 1.69
|
2.1 Score on a 0 to 5 scale
Standard Deviation 1.74
|
|
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
STAT: Itching
|
1.5 Score on a 0 to 5 scale
Standard Deviation 1.53
|
2.2 Score on a 0 to 5 scale
Standard Deviation 1.47
|
|
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
STAT: Pulling
|
1.0 Score on a 0 to 5 scale
Standard Deviation 1.36
|
1.4 Score on a 0 to 5 scale
Standard Deviation 1.66
|
|
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
STAT: Discomfort/Tenderness
|
2.1 Score on a 0 to 5 scale
Standard Deviation 1.57
|
2.5 Score on a 0 to 5 scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.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).
Outcome measures
| Measure |
Mometasone
n=83 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).
|
1.4 score on a 0-6 scale
Standard Deviation 1.24
|
1.7 score on a 0-6 scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.Population: Patients who completed at least 1 assessment were evaluable for this secondary end point.
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).
Outcome measures
| Measure |
Mometasone
n=85 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)
|
85 units on a scale
Standard Deviation 16
|
82 units on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.Population: Patients who completed at least 1 assessment were evaluable for this secondary end point.
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.
Outcome measures
| Measure |
Mometasone
n=85 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
QOL Domains as Measured by LASA
Mental well-being
|
86 units on a scale
Standard Deviation 15
|
84 units on a scale
Standard Deviation 18
|
|
QOL Domains as Measured by LASA
Physical well-being
|
83 units on a scale
Standard Deviation 17
|
79 units on a scale
Standard Deviation 19
|
|
QOL Domains as Measured by LASA
Emotional well-being
|
85 units on a scale
Standard Deviation 16
|
80 units on a scale
Standard Deviation 19
|
|
QOL Domains as Measured by LASA
Social well-being
|
81 units on a scale
Standard Deviation 19
|
77 units on a scale
Standard Deviation 24
|
|
QOL Domains as Measured by LASA
Spiritual well-being
|
89 units on a scale
Standard Deviation 14
|
84 units on a scale
Standard Deviation 21
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.Outcome measures
| Measure |
Mometasone
n=84 Participants
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
n=82 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
ARTHRALGIA: Severe
|
1 participants
|
0 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
BURN: Mild
|
32 participants
|
32 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
BURN: Moderate
|
6 participants
|
5 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
BURN: Severe
|
0 participants
|
2 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
CELLULITES INFECTN: Moderate
|
1 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
COUGH: Severe
|
0 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
DERMATOLOGY: Mild
|
11 participants
|
19 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
DERMATOLOGY: Moderate
|
8 participants
|
3 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
DERMATOLOGY: Severe
|
0 participants
|
2 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
FATIGUE: Moderate
|
0 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PAIN-BREAST: Moderate
|
1 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PAIN-CHEST: Moderate
|
0 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PRURITUS: Mild
|
36 participants
|
50 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PRURITUS: Moderate
|
14 participants
|
14 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PRURITUS: Severe
|
1 participants
|
5 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN ATROPHY: Mild
|
0 participants
|
2 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN ATROPHY: Moderate
|
1 participants
|
0 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN HYPOPIGMENT: Mild
|
5 participants
|
8 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN HYPOPIGMENT: Moderate
|
1 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN IRRITATION: Moderate
|
0 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
PAIN: Severe
|
0 participants
|
1 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN STRIAE: Mild
|
2 participants
|
6 participants
|
|
Adverse Events Assessed Clinically by NCI CTCAE v3.0
SKIN STRIAE: Moderate
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)
Outcome measures
| Measure |
Mometasone
n=83 Participants
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
n=84 Participants
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
|
|---|---|---|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Rash
|
2.6 units on a scale
Standard Deviation 3.38
|
4.0 units on a scale
Standard Deviation 3.96
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Swelling
|
2.3 units on a scale
Standard Deviation 3.29
|
2.4 units on a scale
Standard Deviation 3.14
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Fatigue
|
4.5 units on a scale
Standard Deviation 3.06
|
5.0 units on a scale
Standard Deviation 3.11
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Band, Stripes or Lines
|
1.7 units on a scale
Standard Deviation 2.8
|
1.5 units on a scale
Standard Deviation 2.66
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Redness
|
5.1 units on a scale
Standard Deviation 3.52
|
6.8 units on a scale
Standard Deviation 3.34
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Dry Peeling
|
2.7 units on a scale
Standard Deviation 3.33
|
3.1 units on a scale
Standard Deviation 3.66
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Wet Peeling
|
1.3 units on a scale
Standard Deviation 2.65
|
1.6 units on a scale
Standard Deviation 3.14
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Weeping
|
1.2 units on a scale
Standard Deviation 2.77
|
1.4 units on a scale
Standard Deviation 2.86
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Decrease in color
|
2.3 units on a scale
Standard Deviation 3.12
|
2.1 units on a scale
Standard Deviation 2.81
|
Adverse Events
Mometasone
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mometasone
n=84 participants at risk
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
n=82 participants at risk
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
|
|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/84
|
1.2%
1/82 • Number of events 2
|
|
Infections and infestations
Skin infection
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
76.2%
64/84 • Number of events 235
|
84.1%
69/82 • Number of events 263
|
|
Injury, poisoning and procedural complications
Thermal burn
|
45.2%
38/84 • Number of events 83
|
47.6%
39/82 • Number of events 81
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Reproductive system and breast disorders
Breast pain
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/84
|
1.2%
1/82 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Atrophy skin
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
60.7%
51/84 • Number of events 137
|
84.1%
69/82 • Number of events 214
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
22.6%
19/84 • Number of events 42
|
30.5%
25/82 • Number of events 48
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
7.1%
6/84 • Number of events 14
|
11.0%
9/82 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
3.6%
3/84 • Number of events 12
|
7.3%
6/82 • Number of events 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place