Clinical trial · Interventional
Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrolment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asialia | — | UNRESOLVED | — |
| Hyposalivation | — | UNRESOLVED | — |
| Mouth Dryness | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aqualief | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aqualief® tablets
- description
- oral mucoadesive tablets
- interventionNames
- Dietary Supplement: Aqualief
- type
- PLACEBO_COMPARATOR
- label
- Placebo tablets
- description
- oral mucoadesive tablets
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Saliva Production
- timeFrame
- Change from baseline to 8 days of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available