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

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ClinicalTrials.gov Identifier: NCT03601962
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Latis S.r.l.
Information provided by (Responsible Party):
Helsinn Healthcare SA

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.


Condition or disease Intervention/treatment Phase
Xerostomia Asialia Hyposalivation Mouth Dryness Dietary Supplement: Aqualief Other: Placebo Not Applicable

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®.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, double blind, placebo controlled, cross over study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aqualief® tablets
oral mucoadesive tablets
Dietary Supplement: Aqualief
400mg oral mucoadesive tablets

Placebo Comparator: Placebo tablets
oral mucoadesive tablets
Other: Placebo
400mg Placebo oral mucoadesive tablets




Primary Outcome Measures :
  1. Saliva Production [ Time Frame: Change from baseline to 8 days of treatment ]
    Change of saliva production, without mechanical stimulation.


Secondary Outcome Measures :
  1. pH of the mouth cavity evaluation [ Time Frame: Change from baseline to 8 days of treatment ]
    Change of oral pH

  2. Xerostomia Evaluation (XQ-I questionnaire) [ Time Frame: Change from baseline to 8 days of treatment ]
    Change of xerostomia following treatment

  3. MD Anderson Dysphagia Inventory (MDADI) questionnaire [ Time Frame: Change from baseline to 8 days of treatment ]
    Change of Dysphagia following treatment

  4. Adherence to the treatment by accountability [ Time Frame: Total tablets used from baseline to 8 days of treatment ]
    Accountability of used/unused tablets

  5. Patient's global satisfaction [ Time Frame: from baseline to 8 days of treatment ]
    Report from patients the facility to use and palatability of the product



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601962


Contacts
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Contact: Ester Orlandi, MD +39.02.23900 ext 4000 Ester.Orlandi@istitutotumori.mi.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20100
Contact: Ester Orlandi, MD    +39.02.23900 ext 4000    Ester.Orlandi@istitutotumori.mi.it   
Sponsors and Collaborators
Helsinn Healthcare SA
Latis S.r.l.
Investigators
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Principal Investigator: Ester Orlandi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT03601962     History of Changes
Other Study ID Numbers: HF07-16-31
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helsinn Healthcare SA:
Xerostomia
pH
Saliva
Aqualief
Carnosine
hibiscus
oral health

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases