Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

NCT03601962 | Terminated

• 1 other identifier: HF07-16-31
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Xerostomia; Asialia; Hyposalivation; Mouth Dryness

Keywords

Xerostomia; pH; Saliva; Aqualief; Carnosine; hibiscus; oral health

Outcome Measures

Primary Outcomes (1)

• Saliva Production

  Change of saliva production, without mechanical stimulation.

  Change from baseline to 8 days of treatment

Secondary Outcomes (5)

• pH of the mouth cavity evaluation

  Change from baseline to 8 days of treatment

• Xerostomia Evaluation (XQ-I questionnaire)

  Change from baseline to 8 days of treatment

• MD Anderson Dysphagia Inventory (MDADI) questionnaire

  Change from baseline to 8 days of treatment

• Adherence to the treatment by accountability

  Total tablets used from baseline to 8 days of treatment

• Patient's global satisfaction

  from baseline to 8 days of treatment

Study Arms (2)

Aqualief® tablets

EXPERIMENTAL

oral mucoadesive tablets

Dietary Supplement: Aqualief

Placebo tablets

PLACEBO COMPARATOR

oral mucoadesive tablets

Other: Placebo

Interventions

Aqualief DIETARY_SUPPLEMENT

400mg oral mucoadesive tablets

Aqualief® tablets

Placebo OTHER

400mg Placebo oral mucoadesive tablets

Placebo tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinn Healthcare SA: lead
• Latis S.r.l.: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20100, Italy

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ester Orlandi, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double blind, placebo controlled, cross over study

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: July 31, 2017
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

IT (1)