Trial Outcomes & Findings for Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer (NCT NCT03047174)
NCT ID: NCT03047174
Last Updated: 2020-03-24
Results Overview
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
at 50 Gy (about 5 weeks)
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Arm A: Treatment With Mepitel® Film
Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
|
Arm B: Treatment With Standard Care
Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
9
|
27
|
|
Overall Study
NOT COMPLETED
|
19
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Treatment With Mepitel® Film
n=28 Participants
Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
|
Arm B: Treatment With Standard Care
n=29 Participants
Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Histologic grading
G 3
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Histologic grading
Gx
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Human papilloma virus (HPV) status
Negative
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Human papilloma virus (HPV) status
Positive
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Human papilloma virus (HPV) status
Unknown
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Surgery prior to radiotherapy
No
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Surgery prior to radiotherapy
Yes
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance score
0-1
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance score
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age · <=62 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
Age · >=63 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Tumor site
Oropharynx
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Tumor site
Oral cavity
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tumor site
Hypopharynx
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Tumor site
Larynx
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Tumor stage (American Joint Committee on Cancer)
Stage II
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Tumor stage (American Joint Committee on Cancer)
Stage III
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Tumor stage (American Joint Committee on Cancer)
Stage IV
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Histologic grading
G 1-2
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: Per Protocol Set
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=9 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=27 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)
grade ≥2 radiation dermatitis
|
3 Participants
|
9 Participants
|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)
no grade ≥2 radiation dermatitis
|
6 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: at 60 Gy (about 6 weeks)Population: Per Protocol Set
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=7 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=26 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)
grade ≥2 radiation dermatitis
|
4 Participants
|
15 Participants
|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)
no grade ≥2 radiation dermatitis
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: Per Protocol Set
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=9 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=27 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)
grade ≥3 radiation dermatitis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)
no grade ≥3 radiation dermatitis
|
9 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: at 60 Gy (about 6 weeks)Population: Patients of the Per Protocol Set who were evaluable for radiation dermatitis at 60 Gy.
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=7 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=26 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)
grade ≥3 radiation dermatitis
|
1 Participants
|
3 Participants
|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)
no grade ≥3 radiation dermatitis
|
6 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: Intention-to-Treat Population
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=23 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=28 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)
grade ≥2 radiation dermatitis
|
8 Participants
|
10 Participants
|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)
no grade ≥2 radiation dermatitis
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: at 60 Gy (about 6 weeks)Population: Patients of the Intention-To-Treat Population who were evaluable for radiation dermatitis at 60 Gy.
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=23 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=27 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)
grade ≥2 radiation dermatitis
|
15 Participants
|
16 Participants
|
|
Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)
no grade ≥2 radiation dermatitis
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: Intention-To-Treat Population
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=23 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=28 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)
grade ≥3 radiation dermatitis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)
no grade ≥3 radiation dermatitis
|
23 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: at 60 Gy (about 6 weeks)Population: Patients of the Intention-to-treat Population who were evaluable for radiation dermatitis at 60 Gy.
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=23 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=27 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)
grade ≥3 radiation dermatitis
|
1 Participants
|
3 Participants
|
|
Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)
no grade ≥3 radiation dermatitis
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: up to 50 Gy (about 5 weeks)Population: Patients of the Intention-to-treat Population who were evaluable for median number of radiation fractions (up to 50 Gy) until occurence of grade 2 dermatitis
The number of fractions of radiotherapy up to 50 Gy (50 Gy = 25 fractions) was counted in the intent-to-treat population, until grade 2 radiation dermatitis occurred.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=23 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=28 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis
|
23 number of fractions of radiotherapy
Interval 19.0 to 25.0
|
23 number of fractions of radiotherapy
Interval 9.0 to 25.0
|
SECONDARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: Patients of the Intention-to-treat Population who were evaluable for pain at 50 Gy.
The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=21 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=28 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Median Pain Score at the Irradiated Skin at 50 Gy
|
0.0 score on a scale
Interval 0.0 to 7.0
|
0.0 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: at 60 Gy (about 6 weeks)Population: Patients of the Intention-to-treat Population who were evaluable for pain at 60 Gy.
The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=19 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=26 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Median Pain Score at the Irradiated Skin at 60 Gy
|
2.0 score on a scale
Interval 0.0 to 6.0
|
2.5 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: at 50 Gy (about 5 weeks)Population: For evaluations with the QLQ-C30 questionnaire, data of 19 patients (3 in Arm A, 16 in Arm B) were available, and for evaluations with the QLQ-H\&N35 questionnaire, data of 18 patients (3 in Arm A, 15 in Arm B).
Quality of Life was assessed using the EORTC QLQ-C30 and QLQ-H\&N35 questionnaires. For QLQ-C30, scoring of global health status and functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning) were assessed. Scores ranged from 0 to 100. A higher score represented a higher level of quality of life (global health status) and a higher level of functioning (functional scales). For QLQ-H\&N35, symptom scales (pain, problems with swallowing, senses problems, speech problems, trouble with social eating, trouble with social contact) were assessed Scores ranged from 0 to 100. A higher score represented a higher level of symptomatology/problems. For both questionnaires (QLQ-C30 and QLQ-H\&N35), the change between baseline and follow up at 50 Gy for each item was calculated by using the mean value of the differences between both time points of the evaluable patients.
Outcome measures
| Measure |
Arm A: Treatment With Mepitel® Film
n=3 Participants
Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
Arm B: Treatment With Standard Care
n=16 Participants
Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.
|
|---|---|---|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in physical functioning
|
-2.22 score on a scale
Standard Deviation 7.70
|
-15.0 score on a scale
Standard Deviation 18.14
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding pain
|
-19.44 score on a scale
Standard Deviation 19.25
|
-30.0 score on a scale
Standard Deviation 30.67
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding problems with swallowing
|
-13.89 score on a scale
Standard Deviation 4.81
|
-26.11 score on a scale
Standard Deviation 34.20
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding senses problems
|
-22.22 score on a scale
Standard Deviation 34.69
|
-37.78 score on a scale
Standard Deviation 33.61
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding speech problems
|
-7.41 score on a scale
Standard Deviation 12.83
|
-17.04 score on a scale
Standard Deviation 13.36
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding trouble with social eating
|
-5.56 score on a scale
Standard Deviation 20.97
|
-20.24 score on a scale
Standard Deviation 23.98
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change regarding trouble with social contact
|
-2.22 score on a scale
Standard Deviation 3.85
|
-1.89 score on a scale
Standard Deviation 8.79
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in global health status
|
11.11 score on a scale
Standard Deviation 12.73
|
19.79 score on a scale
Standard Deviation 16.07
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in role functioning
|
0.0 score on a scale
Standard Deviation 16.67
|
-16.67 score on a scale
Standard Deviation 23.57
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in cognitive functioning
|
0.0 score on a scale
Standard Deviation 0.0
|
-4.17 score on a scale
Standard Deviation 20.64
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in emotional functioning
|
-5.56 score on a scale
Standard Deviation 9.62
|
-3.65 score on a scale
Standard Deviation 19.95
|
|
Change in Quality of Life Between Screening and 50 Gy of Radiotherapy
Change in social functioning
|
-16.67 score on a scale
Standard Deviation 23.57
|
1.04 score on a scale
Standard Deviation 26.15
|
Adverse Events
Arm A: Treatment With Mepitel® Film
Serious events: 6 serious events
Other events: 27 other events
Deaths: 2 deaths
Arm B: Treatment With Standard Care
Serious events: 11 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Treatment With Mepitel® Film
n=28 participants at risk
Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
|
Arm B: Treatment With Standard Care
n=29 participants at risk
Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pheochromocytoma
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Skin and subcutaneous tissue disorders
Severe dermatitis
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Gastrointestinal disorders
Mucositis
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
6.9%
2/29 • up to 10 weeks following the start of radiotherapy
|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
6.9%
2/29 • up to 10 weeks following the start of radiotherapy
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Nervous system disorders
Stroke
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Renal and urinary disorders
Acute renal failure
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Methadon overdose
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Investigations
Neutrophil count decreased
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Skin and subcutaneous tissue disorders
Desquamation
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Renal and urinary disorders
Creatinine increased
|
0.00%
0/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
Other adverse events
| Measure |
Arm A: Treatment With Mepitel® Film
n=28 participants at risk
Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
|
Arm B: Treatment With Standard Care
n=29 participants at risk
Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Investigations
whte blood cell decreased
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Renal and urinary disorders
impaired kidney function
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
6.9%
2/29 • up to 10 weeks following the start of radiotherapy
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • up to 10 weeks following the start of radiotherapy
|
3.4%
1/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Distress due to study product/procedure
|
28.6%
8/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Feeling of tightness/suffcoating due to study product/procedure
|
17.9%
5/28 • up to 10 weeks following the start of radiotherapy
|
0.00%
0/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Radiation dermatitis (any grade)
|
89.3%
25/28 • up to 10 weeks following the start of radiotherapy
|
100.0%
29/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Radiation dermatitis (grade >=2)
|
60.7%
17/28 • up to 10 weeks following the start of radiotherapy
|
72.4%
21/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Mucositis (any grade)
|
85.7%
24/28 • up to 10 weeks following the start of radiotherapy
|
96.6%
28/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Mucositis (grade >=2)
|
57.1%
16/28 • up to 10 weeks following the start of radiotherapy
|
69.0%
20/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Taste disorders (any grade)
|
57.1%
16/28 • up to 10 weeks following the start of radiotherapy
|
82.8%
24/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Taste disorders (grade >=2)
|
42.9%
12/28 • up to 10 weeks following the start of radiotherapy
|
55.2%
16/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Xerostomia (any grade)
|
60.7%
17/28 • up to 10 weeks following the start of radiotherapy
|
89.7%
26/29 • up to 10 weeks following the start of radiotherapy
|
|
Injury, poisoning and procedural complications
Xerostomia (grade >=2)
|
25.0%
7/28 • up to 10 weeks following the start of radiotherapy
|
55.2%
16/29 • up to 10 weeks following the start of radiotherapy
|
Additional Information
Prof. Dr. med. Dirk Rades
Department of Radiation Oncology, University of Lübeck, Germany
Phone: 0049 451 500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place