Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

Welcare Industries

Status: Withdrawn

Conditions: Oncology; Quality of Life; Radiodermatitis; Pain

Treatments: Device: Jalosome soothing gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04692389

Welcare 012020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Jalosome® Soothing gel

Experimental group

Description:

The medical device will be applied by the patient himself, after appropriate training carried out by the nurse, twice a day, in the quantity necessary to cover the lesion (0.2g of gel /16 cm2 of skin (one spray), repeated as many times as necessary to cover the entire lesion). The treatment will last 8 weeks. The medical device will be delivered in the quantity strictly necessary to carry out the therapies between visits, in order to monitor its use. Patients will be seen weekly by the nurse, in order to ensure the best continuity of care and promote adherence to the study. Patients will be asked to keep a weekly diary, in which they will report their level of pain, analgesic therapy and medication. Nurses will be available for telephone counselling, if necessary.

Treatment:

Device: Jalosome soothing gel