Back to resultsJalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
Primary Purpose
Radiodermatitis, Oncology, Quality of Life
Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Jalosome soothing gel
Sponsored by
About this trial
This is an interventional treatment trial for Radiodermatitis focused on measuring radiodermatitis, oncology, quality of life, pain, wound healing
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
Sites / Locations
- Oncology Institute Of Southern Switzerland -radio oncology unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jalosome® Soothing gel
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)).
Skindex questionnaire - 16 for quality of life
Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16
Full Information
NCT ID
NCT04692389
First Posted
December 29, 2020
Last Updated
January 24, 2022
Sponsor
Welcare Industries SpA
Collaborators
Oncology Institute of Southern Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04692389
Brief Title
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
difficulties in patients recruitment
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Welcare Industries SpA
Collaborators
Oncology Institute of Southern Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Oncology, Quality of Life, Pain
Keywords
radiodermatitis, oncology, quality of life, pain, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators would like to involve 30 oncology patients with 2 or 3 grade radiodermatitis (based on RTOG score).
All oncology diagnosis will be included.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jalosome® Soothing gel
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Jalosome soothing gel
Other Intervention Name(s)
No other intervention
Intervention Description
This study has not got other intervention
Primary Outcome Measure Information:
Title
Grade 2 or 3 radiodermatitis healing
Description
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 Outcome Measure Information:
Title
Pain quality and intensity
Description
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
Title
Skindex questionnaire - 16 for quality of life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Oncology Institute Of Southern Switzerland -radio oncology unit
City
Bellinzona
State/Province
Canton Ticino
ZIP/Postal Code
6501
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
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