Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel. (NCT05284487) | Clinical Trial Compass
UnknownNot Applicable
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
Italy57 participantsStarted 2023-03-27
Plain-language summary
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:
* To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
* To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
* To investigate safety and tolerability of Jalosome®.
* To investigate patient's compliance to Jalosome® treatment.
* To investigate patient's global satisfaction with Jalosome® treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subject aged ≥18 years old.
* Performance status 0-1.
* Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
* Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
* Willingness and ability to give informed consent and comply with study procedures.
Exclusion Criteria:
* Pregnant or lactating women.
* Previous RT on the head and neck area.
* Planned to receive concurrent cetuximab.
* Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
* Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
* Use of a tissue-equivalent bolus.
* Use of over-the-counter topical medications containing steroids.
* Presence of rashes or unhealed wounds in the radiation field.
* Recent sun exposure (\<1 month).
* Mental conditions that could adversely affect subject's adherence to the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.