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Primary objective
- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.
Secondary objectives:
Primary endpoint:
Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.
• Secondary endpoints:
Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
Patient's compliance to Jalosome® treatment.
Patient's global satisfaction with Jalosome® treatment.
Jalosome® overall safety and tolerability.
Study design:
Monocentric, randomized, double-blind, placebo controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Jalosome® Soothing gel | Active Comparator | Jalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT |
|
| Group 2: Placebo | Placebo Comparator | Placebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jalosome® soothing gel | Device | Jalosome® Soothing gel is a phospholipid based vesicular system based on hyaluronic acid (HA). HA supports the process of formation of extracellular matrix and collagen synthesis by fibroblasts, favoring the formation of a well-vascularized granulation tissue and thus accelerating the healing process. Jalosome® Soothing gel contains other active ingredients: Acetyl-L-carnitine which plays an important role as shuttle for energy production and is involved in cellular metabolism. It is an effective cytoprotective, anti-inflammatory, neuroprotective, metal chelator, anti-apoptotic and anti-oxidant agent. Allantoin is a key constituent of comfrey (Symphytum officinale L), it has moisturizing and keratolytic effect, increasing the water content of the extracellular matrix and enhancing desquamation of upper layers of dead skin cells. Hydrogenated phosphatidylcholine is a permeation enhancers, which increases the solubilization of active ingredients, improving their skin permeation ability. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to development of G2 RID | Mean number of days in development of G2 RID (according to CTCA), in the Jalosome® and placebo arms. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects without G2 RID at the end of RT | Number and percentage of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.. | 9 weeks |
| Subjects without G2 RID at different timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Gobbino | Contact | +39 (0)763 316353 | r&s@welcaremedical.com | |
| Fulvia Lazzarotto, CEO | Contact | +39 (0)763 316353 | fl@welcaremedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicola Alessandro Iacovelli | Fondazione IRCCS ISTITUTO NAZIONALE TUMORI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS | Recruiting | Milan | 20133 | Italy |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| Placebo | Device | The placebo does not contain the active ingredients of Jalosome, only the co-formulants. |
|
Number and percentage of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
| 9 weeks |
| Worst skin toxicity | Number and percentage of subjects with worst skin toxicity G3, G2 and G1 RID according to CTCAE v.4.0, during treatment and up to 2 weeks after the last administration of RT, in the Jalosome® and placebo arms. | 9 weeks |
| RID grade on the RISRAS | Mean RID grade on the Radiation-Induced Skin Reaction Assessment Scale scale (RISRAS), assessed weekly, in the Jalosome® and placebo arms. RISRAS score varies from 0 to 36, where 0 is normal skin/no symptoms at all and 36 is the worst conditions in terms of erythema-Dry desquamation - Moist desquamation - necrosis of derma (14 points) and very severe symptoms (12 points). | 9 weeks |
| PRO-Skindex-16 questionnaire score | Mean score of each item (16 items) of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms. Each item is about skin discomfort, ancd the scores vary from 0 (no discomfort) to 6 (full discomfort). | 9 weeks |
| Pain measured by NRS | Mean pain measured by the 11-point Numeric rating scale (NRS) of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms. NRS score varies from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | 9 weeks |
| Compliance | Number and percentage of patients with compliance to Jalosome® treatment ≥80%. | 9 weeks |
| Adverse events | Number and percentage of adverse events by grade, according to the CTCAE v.4.0, and relationship with the treatment. | 9 weeks |
| D014947 |
| Wounds and Injuries |