XerostomiaNCT03601962
Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
A study testing Aqualief in people with Xerostomia and Asialia, run by Helsinn Healthcare SA at 1 site in Italy.
Trial summary
The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections. Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Asialia, Hyposalivation
- What is being tested?
- Aqualief
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2017to 22 Jan 2020
- 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
- Male and female which are 18 years of age or older
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
- Subjects presenting:hyposalivation of grade 2 or greater (according to CTCAE scale vers. 4) and an objective, unstimulated salivary flow between 0.1 and 0.25 ml/min following radiation or radiation + systemic therapies with curative intent (definitive or postoperative), for tumors located in the head / neck region, completed from at least 6 months and free from cancer disease
- Absence of infections in the oral cavity
- Absence of antibiotics and antifungal treatments or any odontoiatric procedure in the 10 days before each treatment phase of the study.
Who cannot join
- Contraindications in administration of carnosine and hibiscus
- Known hypersensitivity to the components present in the product.
- Subjects taking products or medications to reduce symptoms of salivary gland hypofunction (Pilocarpine etc.)
- Patients with other underlying conditions that can cause xerostomia.
- Use of experimental drugs within 30 days prior to enrollment or during the study.
- Presence of clinical conditions that may interfere with the study evaluations.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effects of Aqualief® Mucoadhesive Tablets (a Food Supplement Based on Carnosine and Hibiscus) in Patients Who Developed Oral Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections.
Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.
Read the detailed description
Xerostomia is the biggest and chronic side effect of the RT for head and neck cancer. To treat xerostomia different approach should be followed at the same time: to increase existing saliva flow or replace lost secretions, to control the state of oral health, to control dental caries and to treat possible infections18.
When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
The salivary flow can be stimulated by the use of sugarless chewing gum or xylitol/sorbitol candy or through parasympathomimetic drug such as pilocarpine. Pilocarpine is a natural alkaloid that activates cholinergic receptors, authorized to treat xerostomia. Due to its main mechanism of action, pilocarpine has some muscarinic side effects19, especially vomiting, sweating, headache, increased urinary frequency, wheezing, watery eyes, nausea and gastrointestinal intolerance, hypotension, rhinitis, diarrhea, and visual disturbances. Pilocarpine has also some use restrictions that make it not prescribable to certain patients (patients with asthma, high blood pressure, heart diseases and in therapy with β-blockers cannot use pilocarpine because this drug is a nonselective antagonist of muscarinic receptors and, therefore, it can interfere with the cardiac and respiratory functions).
Acupuncture seems to alleviate radio-induced xerostomia but it mechanism of action is not totally clear and systematic reviews indicate its efficacy as doubtful20,21.
Other products are under investigation and their efficacy in xerostomia due to RT is still unclear.
Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.
Aqualief® is designed as a mucoadesive tablet that will adhere to the cheek internal side, to have a prolonged action. It is expected to gradually release the ingredients over a period of at least two hours.
Aqualief® is being tested in a clinical study on 70 subjects with grade 1-2 xerostomy enrolled at the Dental Clinic of the University of Insubria. The study is currently ongoing therefore results are not yet available.
The aim of this clinical study is to evaluate if Aqualief® can be efficacious in the increasing of the saliva production in patients suffering for xerostomia as consequence of previous RT for head and neck cancer.
To this purpose, this double blind cross over study has been designed: 100 patients will be treated for 8 days with Aqualief®/placebo and then, following a 10 days wash-out period, for further 8 days with placebo /Aqualief®.
- Conditions
- Xerostomia, Asialia, Hyposalivation, Mouth Dryness
- Being tested
- Aqualief, Placebo
- Keywords
- Xerostomia, pH, Saliva, Aqualief, Carnosine, hibiscus, oral health
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AqualiefDietary supplement
400mg oral mucoadesive tablets
PlaceboOther
400mg Placebo oral mucoadesive tablets
| Study group | Role | What they receive |
|---|---|---|
| Aqualief® tablets | Experimental | oral mucoadesive tablets Receives: Dietary Supplement: Aqualief |
| Placebo tablets | Placebo comparator | oral mucoadesive tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva Production
Change of saliva production, without mechanical stimulation.
Measured: Change from baseline to 8 days of treatment
Secondary outcomes (5)
pH of the mouth cavity evaluation
Change of oral pH
Measured: Change from baseline to 8 days of treatment
Xerostomia Evaluation (XQ-I questionnaire)
Change of xerostomia following treatment
Measured: Change from baseline to 8 days of treatment
MD Anderson Dysphagia Inventory (MDADI) questionnaire
Change of Dysphagia following treatment
Measured: Change from baseline to 8 days of treatment
Adherence to the treatment by accountability
Accountability of used/unused tablets
Measured: Total tablets used from baseline to 8 days of treatment
Patient's global satisfaction
Report from patients the facility to use and palatability of the product
Measured: from baseline to 8 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start31 Jul 2017
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Low enrolment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- randomized, double blind, placebo controlled, cross over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l.
- Responsible party
- Sponsor
- Investigators
- Ester Orlandi, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601962
- Sponsor's protocol ID
- HF07-16-31
- Status last verified
- Jan 2020
- First submitted
- 2 Jul 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effects of Aqualief® Mucoadhesive Tablets (a Food Supplement Based on Carnosine and Hibiscus) in Patients Who Developed Oral Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03601962
- Acronym / sponsor ID
- HF07-16-31
- Conditions
- Xerostomia, Asialia, Hyposalivation, Mouth Dryness
- Keywords
- Xerostomia, pH, Saliva, Aqualief, Carnosine, hibiscus, oral health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrolment rate
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l.
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 26 Jul 2018 (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.
The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections.
Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.
Detailed description
Xerostomia is the biggest and chronic side effect of the RT for head and neck cancer. To treat xerostomia different approach should be followed at the same time: to increase existing saliva flow or replace lost secretions, to control the state of oral health, to control dental caries and to treat possible infections18.
When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.
The salivary flow can be stimulated by the use of sugarless chewing gum or xylitol/sorbitol candy or through parasympathomimetic drug such as pilocarpine. Pilocarpine is a natural alkaloid that activates cholinergic receptors, authorized to treat xerostomia. Due to its main mechanism of action, pilocarpine has some muscarinic side effects19, especially vomiting, sweating, headache, increased urinary frequency, wheezing, watery eyes, nausea and gastrointestinal intolerance, hypotension, rhinitis, diarrhea, and visual disturbances. Pilocarpine has also some use restrictions that make it not prescribable to certain patients (patients with asthma, high blood pressure, heart diseases and in therapy with β-blockers cannot use pilocarpine because this drug is a nonselective antagonist of muscarinic receptors and, therefore, it can interfere with the cardiac and respiratory functions).
Acupuncture seems to alleviate radio-induced xerostomia but it mechanism of action is not totally clear and systematic reviews indicate its efficacy as doubtful20,21.
Other products are under investigation and their efficacy in xerostomia due to RT is still unclear.
Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.
Aqualief® is designed as a mucoadesive tablet that will adhere to the cheek internal side, to have a prolonged action. It is expected to gradually release the ingredients over a period of at least two hours.
Aqualief® is being tested in a clinical study on 70 subjects with grade 1-2 xerostomy enrolled at the Dental Clinic of the University of Insubria. The study is currently ongoing therefore results are not yet available.
The aim of this clinical study is to evaluate if Aqualief® can be efficacious in the increasing of the saliva production in patients suffering for xerostomia as consequence of previous RT for head and neck cancer.
To this purpose, this double blind cross over study has been designed: 100 patients will be treated for 8 days with Aqualief®/placebo and then, following a 10 days wash-out period, for further 8 days with placebo /Aqualief®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double blind, placebo controlled, cross over study
| Arm | Type | Receives |
|---|---|---|
| Aqualief® tablets | Experimental | Dietary Supplement: Aqualieforal mucoadesive tablets |
| Placebo tablets | Placebo comparator | Other: Placebooral mucoadesive tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female which are 18 years of age or older
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
- Subjects presenting:hyposalivation of grade 2 or greater (according to CTCAE scale vers. 4) and an objective, unstimulated salivary flow between 0.1 and 0.25 ml/min following radiation or radiation + systemic therapies with curative intent (definitive or postoperative), for tumors located in the head / neck region, completed from at least 6 months and free from cancer disease
- Absence of infections in the oral cavity
- Absence of antibiotics and antifungal treatments or any odontoiatric procedure in the 10 days before each treatment phase of the study.
Key exclusion criteria (7 listed)
- Contraindications in administration of carnosine and hibiscus
- Known hypersensitivity to the components present in the product.
- Subjects taking products or medications to reduce symptoms of salivary gland hypofunction (Pilocarpine etc.)
- Patients with other underlying conditions that can cause xerostomia.
- Use of experimental drugs within 30 days prior to enrollment or during the study.
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 |
|---|---|---|
| Aqualief400mg oral mucoadesive tablets | Dietary supplement | Aqualief® tablets |
| Placebo400mg Placebo oral mucoadesive tablets | Other | Placebo tablets |
Primary outcome
Saliva Production
Time frame: Change from baseline to 8 days of treatment
Change of saliva production, without mechanical stimulation.
5 secondary outcomes
pH of the mouth cavity evaluation
Time frame: Change from baseline to 8 days of treatment
Xerostomia Evaluation (XQ-I questionnaire)
Time frame: Change from baseline to 8 days of treatment
MD Anderson Dysphagia Inventory (MDADI) questionnaire
Time frame: Change from baseline to 8 days of treatment
Adherence to the treatment by accountability
Time frame: Total tablets used from baseline to 8 days of treatment
Patient's global satisfaction
Time frame: from baseline to 8 days of treatment
Results and safety
The study was stopped early (reason given: Low enrolment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Ester Orlandi, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqualief in people with Xerostomia and Asialia, run by Helsinn Healthcare SA 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jan 2020. 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 was stopped early (reason given: Low enrolment rate). Results are not available in the source record.
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?
Saliva Production (time frame: Change from baseline to 8 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.