XerostomiaNCT05103124
GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation.
A study testing Hydral in people with Xerostomia and Xerostomia Following Radiotherapy, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Xerostomia Following Radiotherapy
- What is being tested?
- Hydral
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2020to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of GUM Hydral Mouthwashes on Symptoms of Radiotherapy-induced Xerostomia: a Randomized, Double-blind, Crossover Study.
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.
Read the detailed description
Head and neck squamous cell carcinoma (HNSCC) accounts for more than 750,000 new cases per year and its prognosis is still poor in terms of mortality and of morbidity and it causes approximately 350,000 deaths annually worldwide. Radiotherapy (RT) is an established treatment modality for HNSCC and other H\&N tumors, either for treatment alone or as adjuvant. Unfortunately, high-dose RT has significant adverse effects on the oral and maxillofacial tissues, both hard and soft. In particular, when salivary glands are within the irradiated field, irreversible salivary glands damage occurs in 63-93% of the patients. Salivary gland damage typically manifests as reduced saliva secretion, which in turn can translate into a subjective sensation of dry mouth (xerostomia), oral discomfort, altered taste, difficulty with speaking, swallowing, chewing, and increased risk of dental disease. Overall hyposalivation and related xerostomia can cause a substantial reduction in quality-of-life (QoL). However 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.
GUM Hydral (GUM Hydral: Sunstar Italiana SRL. Corso Italia 13 21047 Saronno, VA, Italy) is a product based on hyaluronic acid and sodium citrate. It helps in rehydrating and protecting the oral tissues, by forming a film on those tissues. It may be helpful in reducing the xerostomia symptoms.
The device is a high-density liquid and it is used as a mouthwash. In this trial, the aim is to investigate if its efficacy in reducing the xerostomia symptoms is higher than placebo.
The placebo will be made of water with xylitol in addition. Xylitol is a is a sugar alcohol used as a sugar substitute, which does not increase the risk of tooth decay. In this formulation, its only role is to give a slight sweet flavor to water.
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.
- Conditions
- Xerostomia, Xerostomia Following Radiotherapy
- Being tested
- Hydral, Placebo
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydralDevice
The investigational product GUM Hydral will be administered for a 30-days treatment period
PlaceboOther
The placebo product will be administered for a 30-days treatment period
| Study group | Role | What they receive |
|---|---|---|
| Hydral | Experimental | The participants will be asked to rinse their mouth five times a day with the experimental product. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35) Receives: Device: Hydral; Other: Placebo |
| Placebo | Placebo comparator | The participants will be asked to rinse their mouth five times a day with the placebo comparator. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35) Receives: Device: Hydral; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the Xerostomia Questionnaire (XQ)
The modified XQ provides a measure of the severity of radiation -induced xerostomia that affects the patients' QoL. This questionnaire consists of 10 questions, associated with patient-reported dryness. Moreover, a general question "how dry is your mouth?" has been added to the questionnaire. The modified XQ is a self-administered tool and patients will be asked to rate each symptom on a 10-point NRS scale of 0-10, with higher scores indicating more severe dryness or discomfort due to dryness. Each item score is added, and the sum is linearly transformed to produce the final summary score ranging from 0 to 100, with higher scores representing higher levels of xerostomia.
Measured: After a one-month therapy both with Hydral and Placebo
Secondary outcomes (2)
Improvement of the EORTC QLQ-30 questionnaire
The QLQ-C30 provides 30 questions, globally assessing patients' quality of life. The answers will be converted into a linear scoring scale, with values between 0 and 100, as advocated by EORTC.
Measured: After a one-month therapy both with Hydral and Placebo
Improvement of the EORTC QLQ_H&N-35 Questionnaire
The QLQ-H\&N35 includes 35 questions, and addresses symptoms associated with specific tumor location, side effects associated with the oncologic treatment and additional QoL aspects modified by the disease or its treatment. The answers will be converted into a linear scoring scale, with values between 0 and 100, as advocated by EORTC.
Measured: After a one-month therapy both with Hydral and Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start3 Nov 2020
- Primary completion31 Dec 2021
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar Italiana SRL.
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
- Investigators
- Carlo Lajolo, Prof., Principal investigator, CU Sacred Hearth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103124
- Sponsor's protocol ID
- SSHNC-1
- Status last verified
- Jul 2022
- First submitted
- 17 Oct 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rupe C, Basco A, Gioco G, Patini R, Lucchese A, Micciche F, Massaccesi M, Lajolo C. Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial. Support Care Cancer. 2023 Oct 18;31(12):644. doi: 10.1007/s00520-023-08090-x.
PubMed 37851095
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of GUM Hydral Mouthwashes on Symptoms of Radiotherapy-induced Xerostomia: a Randomized, Double-blind, Crossover Study.
- ClinicalTrials.gov ID
- NCT05103124
- Acronym / sponsor ID
- SSHNC-1
- Conditions
- Xerostomia, Xerostomia Following Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Sunstar Italiana SRL.
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Head and neck squamous cell carcinoma (HNSCC) accounts for more than 750,000 new cases per year and its prognosis is still poor in terms of mortality and of morbidity and it causes approximately 350,000 deaths annually worldwide. Radiotherapy (RT) is an established treatment modality for HNSCC and other H\&N tumors, either for treatment alone or as adjuvant. Unfortunately, high-dose RT has significant adverse effects on the oral and maxillofacial tissues, both hard and soft. In particular, when salivary glands are within the irradiated field, irreversible salivary glands damage occurs in 63-93% of the patients. Salivary gland damage typically manifests as reduced saliva secretion, which in turn can translate into a subjective sensation of dry mouth (xerostomia), oral discomfort, altered taste, difficulty with speaking, swallowing, chewing, and increased risk of dental disease. Overall hyposalivation and related xerostomia can cause a substantial reduction in quality-of-life (QoL). However 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.
GUM Hydral (GUM Hydral: Sunstar Italiana SRL. Corso Italia 13 21047 Saronno, VA, Italy) is a product based on hyaluronic acid and sodium citrate. It helps in rehydrating and protecting the oral tissues, by forming a film on those tissues. It may be helpful in reducing the xerostomia symptoms.
The device is a high-density liquid and it is used as a mouthwash. In this trial, the aim is to investigate if its efficacy in reducing the xerostomia symptoms is higher than placebo.
The placebo will be made of water with xylitol in addition. Xylitol is a is a sugar alcohol used as a sugar substitute, which does not increase the risk of tooth decay. In this formulation, its only role is to give a slight sweet flavor to water.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydral | Experimental | Device: Hydral, Other: PlaceboThe participants will be asked to rinse their mouth five times a day with the experimental product. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35) |
| Placebo | Placebo comparator | Device: Hydral, Other: PlaceboThe participants will be asked to rinse their mouth five times a day with the placebo comparator. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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-
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydralThe investigational product GUM Hydral will be administered for a 30-days treatment period | Device | Hydral, Placebo |
| PlaceboThe placebo product will be administered for a 30-days treatment period | Other | Hydral, Placebo |
Primary outcome
Improvement of the Xerostomia Questionnaire (XQ)
Time frame: After a one-month therapy both with Hydral and Placebo
The modified XQ provides a measure of the severity of radiation -induced xerostomia that affects the patients' QoL. This questionnaire consists of 10 questions, associated with patient-reported dryness. Moreover, a general question "how dry is your mouth?" has been added to the questionnaire. The modified XQ is a self-administered tool and patients will be asked to rate each symptom on a 10-point NRS scale of 0-10, with higher scores indicating more severe dryness or discomfort due to dryness. Each item score is added, and the sum is linearly transformed to produce the final summary score ranging from 0 to 100, with higher scores representing higher levels of xerostomia.
2 secondary outcomes
Improvement of the EORTC QLQ-30 questionnaire
Time frame: After a one-month therapy both with Hydral and Placebo
Improvement of the EORTC QLQ_H&N-35 Questionnaire
Time frame: After a one-month therapy both with Hydral and Placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 37851095Rupe C, Basco A, Gioco G, Patini R, Lucchese A, Micciche F, Massaccesi M, Lajolo C. Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial. Support Care Cancer. 2023 Oct 18;31(12):644. doi: 10.1007/s00520-023-08090-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Lajolo, Prof. principal investigator
CU Sacred Hearth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydral in people with Xerostomia and Xerostomia Following Radiotherapy, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the Xerostomia Questionnaire (XQ) (time frame: After a one-month therapy both with Hydral and Placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.