GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation. (NCT05103124) | Clinical Trial Compass
CompletedNot Applicable
GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation.
Italy40 participantsStarted 2020-11-03
Plain-language summary
There is currently little robust evidence to inform the management of hyposalivation and xerostomia in this population. Although the treatment of xerostomia is very individual, a first-line medication is needed to ameliorate the dehydration in the mouth by substituting for the secretion of saliva.
The aim of this study is to describe the effect of the administration of Hydral on reducing patients' xerostomia symptoms due to radiotherapy.
The study will be conducted as a double-blind randomized clinical trial (RCT) and foresees a crossover design, so the population will be divided into two groups, receiving both the medical device and the placebo.
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:
* Patients willing to sign the informed consent form
* Patients older than 18 years
* Patients with diagnosis of HNC, who had received local radiotherapy at least three months before the beginning of the study, involving the salivary glands, both for curative and palliative purpose, with or without chemotherapic treatment, reporting xerostomia symptoms
* Patients with diagnosis of HNC, who had received local radiotherapy as an adjuvant to surgical resection at least three months before the beginning of the study, with or without chemotherapic treatment, reporting xerostomia symptoms-
Exclusion Criteria:
* Patients with documented contraindication to any of the components of GUM HYDRAL (there included eccipients)
* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
* Patients unwilling to complete the request diary card
* Patients unable to attend the ambulatory visits scheduled by the protocol
* Patients participating to other clinical studies
* Patients who had received antitumoral treatment during the previous three months
* Patients with concomitant Sjogren's syndrome
* Other causes of xerostomia (pharmacological treatment)
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.
What they're measuring
1
Improvement of the Xerostomia Questionnaire (XQ)
Timeframe: After a one-month therapy both with Hydral and Placebo