JOURNAL ONKOLOGIE – STUDIE
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
Noch nicht rekrutierend
NCT-Nummer:
NCT04692389
Studienbeginn:
Februar 2021
Letztes Update:
05.01.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Neoplasms, Radiodermatitis
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Welcare Industries SpA
Collaborator:
Oncology Institute of Southern Switzerland
Studienlocations
(1 von 1)
6501 Bellinzona
Switzerland» Google-Maps
Ansprechpartner:
Loris Bonetti
Phone: +41918118957
E-Mail: loris.bonetti@eoc.ch
Giovanni Presta
Phone: +41918118132
E-Mail: giovanni.presta@eoc.ch» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome:1. Grade 2 or 3 radiodermatitis healing (Time Frame - 8 weeks):
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.
Secondary outcome:
1. Pain quality and intensity (Time Frame - 8 weeks):
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)).
2. Skindex questionnaire - 16 for quality of life (Time Frame - at the beginning, after 4 weeks and after 8 weeks):
Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16
Geprüfte Regime
- Jalosome soothing gel (No other intervention):
This study has not got other intervention
Quelle: ClinicalTrials.gov
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