Trial Outcomes & Findings for Impact of Applying a Bandage Skin Hydrogel on the Pains of the Head and Neck in Patients With Cancer of Head and Neck Treated With Radiotherapy (NCT NCT01520701)
NCT ID: NCT01520701
Last Updated: 2026-09-01
Results Overview
Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to that obtained at baseline (D0).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
end of radiotherapy (2 months after inclusion)
Results posted on
2026-09-01
Participant Flow
Participant milestones
| Measure |
Ialuset® Application
Arm with application to the skin Ialuset ® cervical during radiotherapy
|
Bandage Skin Hydrosorb
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
38
|
44
|
|
Overall Study
NOT COMPLETED
|
28
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ialuset® Application
n=38 Participants
Arm with application to the skin Ialuset ® cervical during radiotherapy
|
Bandage Skin Hydrosorb
n=44 Participants
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
n=38 Participants
|
60.0 years
n=44 Participants
|
59.9 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=38 Participants
|
6 Participants
n=44 Participants
|
11 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=38 Participants
|
38 Participants
n=44 Participants
|
71 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Cancer localisation
oral cavity
|
12 Participants
n=38 Participants
|
8 Participants
n=44 Participants
|
20 Participants
n=82 Participants
|
|
Cancer localisation
oropharynx
|
11 Participants
n=38 Participants
|
17 Participants
n=44 Participants
|
28 Participants
n=82 Participants
|
|
Cancer localisation
hypopharynx
|
7 Participants
n=38 Participants
|
11 Participants
n=44 Participants
|
18 Participants
n=82 Participants
|
|
Cancer localisation
larynx
|
5 Participants
n=38 Participants
|
5 Participants
n=44 Participants
|
10 Participants
n=82 Participants
|
|
Cancer localisation
unknown primary
|
1 Participants
n=38 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=82 Participants
|
|
Cancer localisation
other
|
2 Participants
n=38 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: end of radiotherapy (2 months after inclusion)Population: 5 patients do not answer to the score algia EVA rating scale at the inclusion visit.
Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to that obtained at baseline (D0).
Outcome measures
| Measure |
Ialuset® Application
n=37 Participants
Arm with application to the skin Ialuset ® cervical during radiotherapy
|
Bandage Skin Hydrosorb
n=40 Participants
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
|
|---|---|---|
|
Impact of Applying a Bandage Hydrogel Skin on Head and Neck Pains
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: during 36 months after radiotherapyPopulation: All patients were analyzed
Evaluating the terms of issue of the treatment (dose reduction of chemothrapy treatment)
Outcome measures
| Measure |
Ialuset® Application
n=38 Participants
Arm with application to the skin Ialuset ® cervical during radiotherapy
|
Bandage Skin Hydrosorb
n=44 Participants
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
|
|---|---|---|
|
Chemotherapy Dose Reduction
|
8 Participants
|
8 Participants
|
Adverse Events
Ialuset® Application
Serious events: 0 serious events
Other events: 38 other events
Deaths: 14 deaths
Bandage Skin Hydrosorb
Serious events: 0 serious events
Other events: 44 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ialuset® Application
n=38 participants at risk
Arm with application to the skin Ialuset ® cervical during radiotherapy
|
Bandage Skin Hydrosorb
n=44 participants at risk
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
97.4%
37/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
88.6%
39/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Gastrointestinal disorders
Larynx hoarseness
|
26.3%
10/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
36.4%
16/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
25.0%
11/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Gastrointestinal disorders
Salivary glands dryness
|
5.3%
2/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
0.00%
0/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
6.8%
3/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Infections and infestations
Respiratory insufficiency
|
7.9%
3/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
0.00%
0/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Gastrointestinal disorders
Dysphagia
|
78.9%
30/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
68.2%
30/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Gastrointestinal disorders
Mucotisis
|
100.0%
38/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
86.4%
38/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
38/38 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
0.00%
0/44 • During the 36 months after the end of radiotherapy
The severity of adverse events was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0 (grades 1-5) for chemotherapy-related toxicities and according to the EORTC/RTOG Morbidity Criteria for acute and late radiotherapy-related toxicities. Adverse events not covered by these classifications were graded using the following severity categories: Grade 1 (mild), events not affecting usual daily activities; Grade 2 (moderate), eve
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place