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

Primary Purpose

Xerostomia, Asialia, Hyposalivation

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aqualief
Placebo
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, pH, Saliva, Aqualief, Carnosine, hibiscus, oral health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aqualief® tablets

Placebo tablets

Arm Description

oral mucoadesive tablets

oral mucoadesive tablets

Outcomes

Primary Outcome Measures

Saliva Production
Change of saliva production, without mechanical stimulation.

Secondary Outcome Measures

pH of the mouth cavity evaluation
Change of oral pH
Xerostomia Evaluation (XQ-I questionnaire)
Change of xerostomia following treatment
MD Anderson Dysphagia Inventory (MDADI) questionnaire
Change of Dysphagia following treatment
Adherence to the treatment by accountability
Accountability of used/unused tablets
Patient's global satisfaction
Report from patients the facility to use and palatability of the product

Full Information

First Posted
July 2, 2018
Last Updated
January 22, 2020
Sponsor
Helsinn Healthcare SA
Collaborators
Latis S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT03601962
Brief Title
Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrolment rate
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
Collaborators
Latis S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Asialia, Hyposalivation, Mouth Dryness
Keywords
Xerostomia, pH, Saliva, Aqualief, Carnosine, hibiscus, oral health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, double blind, placebo controlled, cross over study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aqualief® tablets
Arm Type
Experimental
Arm Description
oral mucoadesive tablets
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
oral mucoadesive tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Aqualief
Intervention Description
400mg oral mucoadesive tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
400mg Placebo oral mucoadesive tablets
Primary Outcome Measure Information:
Title
Saliva Production
Description
Change of saliva production, without mechanical stimulation.
Time Frame
Change from baseline to 8 days of treatment
Secondary Outcome Measure Information:
Title
pH of the mouth cavity evaluation
Description
Change of oral pH
Time Frame
Change from baseline to 8 days of treatment
Title
Xerostomia Evaluation (XQ-I questionnaire)
Description
Change of xerostomia following treatment
Time Frame
Change from baseline to 8 days of treatment
Title
MD Anderson Dysphagia Inventory (MDADI) questionnaire
Description
Change of Dysphagia following treatment
Time Frame
Change from baseline to 8 days of treatment
Title
Adherence to the treatment by accountability
Description
Accountability of used/unused tablets
Time Frame
Total tablets used from baseline to 8 days of treatment
Title
Patient's global satisfaction
Description
Report from patients the facility to use and palatability of the product
Time Frame
from baseline to 8 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Orlandi, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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