Pain Clinical Trial
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.
Verified date | January 2022 |
Source | Welcare Industries SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Oncology Institute Of Southern Switzerland -radio oncology unit | Bellinzona | Canton Ticino |
Lead Sponsor | Collaborator |
---|---|
Welcare Industries SpA | Oncology Institute of Southern Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
8 weeks | |
Secondary | 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)). | 8 weeks | |
Secondary | Skindex questionnaire - 16 for quality of life | Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16 | at the beginning, after 4 weeks and after 8 weeks |
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