Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

NCT ID: NCT04692389

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-03-31

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.

Conditions

Radiodermatitis; Oncology; Quality of Life; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jalosome® Soothing gel

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.

Group Type: EXPERIMENTAL

Jalosome soothing gel

Intervention Type: DEVICE

This study has not got other intervention

Interventions

Jalosome soothing gel

This study has not got other intervention

Intervention Type: DEVICE

Other Intervention Names

No other intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncology Institute of Southern Switzerland

OTHER

Sponsor Role: collaborator

Welcare Industries SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oncology Institute Of Southern Switzerland -radio oncology unit

Bellinzona, Canton Ticino, Switzerland

Countries

Switzerland

Other Identifiers

Welcare 012020

Identifier Type: -

Identifier Source: org_study_id