Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

Welcare Industries SpA

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Radiodermatitis Oncology Quality of Life Pain

Interventions

Jalosome soothing gelDEVICE

This study has not got other intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oncology Institute Of Southern Switzerland -radio oncology unit

Bellinzona, Canton Ticino, Switzerland

Outcomes

Primary Outcomes

Grade 2 or 3 radiodermatitis healing

The primary endpoint is the number of grade 2 or 3 radiodermatitis healed by the application of Jalosome® soothing gel during the observation period, out of the total number of patients treated. This endpoint will be assessed by photographic documentation of lesion improvement and healing and with the aid of the RGOT scale (which should regress from grade 2 or 3 to grade 0 or 1). The time to regression of the lesion will also be monitored on this same endpoint in order to establish the rate of efficacy of the product against grade 2 and 3 lesions.

Time frame: 8 weeks

Secondary Outcomes

Pain quality and intensity

The first secondary endpoint will be the intensity and quality of pain, measured respectively by the NRS scale and by questions on the type of pain perceived (twinge, burning, pins, allodynia (i.e. a painful impulse following a harmless stimulus), cramp-like, piercing (stab-like)).

Time frame: 8 weeks

Skindex questionnaire - 16 for quality of life

Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16

Time frame: at the beginning, after 4 weeks and after 8 weeks

Data from ClinicalTrials.gov

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