Clinical trial NCT04692389: Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
Official title: The Efficacy of the Medical Device Jalosome® Soothing Gel in the Healing of Grade of 2 or 3 Radiodermatitis, Pain Intensity Reduction, as Well as Improvement of QoL in Oncology Patients: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Radiodermatitis
Oncology
Quality of Life
Pain
Keywords: radiodermatitis
oncology
quality of life
pain
wound healing
Lead sponsor: Welcare Industries SpA
Sponsor class: INDUSTRY
Collaborators: name: Oncology Institute of Southern Switzerland
First posted: 2020-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators would like to involve 30 oncology patients with 2 or 3 grade radiodermatitis (based on RTOG score).

All oncology diagnosis will be included.
Primary purpose: TREATMENT

Brief summary: Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients.

The investigators would like to know also the efficacy of the device on quality of life and pain.

Detailed description: The overall objective of the study is to evaluate the efficacy of the class IIA medical device Jalosome® soothing gel in the healing of grade 2 or 3 radiodermatitis, in oncology patients undergoing radiotherapy treatment, during a 8-week observation period.

The secondary endpoints are radiodermatitis pain control and quality of life.

The investigators would like to involve 30 oncology patients. All oncology diagnosis will be included in this pilot study. The study will adopt a quasi-experimental design with one arm. The results will be used to determine the sample size for a clinical trial in which the class IIA medical device Jalosome® soothing gel will be compared to usual care.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Patients with cancer\* undergoing radiotherapy treatment
* Patients with grade 2 or 3 radiotherapy lesions who are naive to radiodermatitis treatment or unresponsive to previous treatment
* Patients who have given written informed consent
* Patients expected to be followed at the centre for at least 8 weeks
* Patients with Karnofsky Performance Status(KPS) scale ≥ 40

Exclusion Criteria:

* Patients with grade 1 and grade IV radiodermatitis
* Patients with known intolerance to the components in Jalosome® soothing gel
* Patients who have already received radiotherapy in the past on the irradiated area
* Patients with cognitive impairment that does not allow adequate compliance with the protocol
* Patients with brain metastases
* Pregnant or lactating patients
* Patients with KPS \< 40

Primary outcomes:
measure: Grade 2 or 3 radiodermatitis healing
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain quality and intensity
timeFrame: 8 weeks
measure: Skindex questionnaire - 16 for quality of life
timeFrame: at the beginning, after 4 weeks and after 8 weeks
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute Of Southern Switzerland -radio oncology unit
state: Canton Ticino
Study officials:
References: