Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

NCT02705937 | Unknown

• 1 other identifier: API/2015/65
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency). The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia. This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals. This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.

Conditions

Xerostomia

Keywords

xerostomia, Saliva, iatrogenic oral dryness, dairy product

Outcome Measures

Primary Outcomes (1)

• Comparison of changes in mouth Dryness Score

  Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21

  Score measured at day 0, day 14, Day 21 and day 35

Secondary Outcomes (8)

• Difficulty in chewing

  Score measured at day 0, day 14, Day 21 and day 35

• Difficulty in swallowing

  Score measured at day 0, day 14, Day 21 and day 35

• Difficulty in speaking

  Score measured at day 0, day 14, Day 21 and day 35

• Burning sensation

  Score measured at day 0, day 14, Day 21 and day 35

• Taste perception

  Score measured at day 0, day 14, Day 21 and day 35

Study Arms (2)

Dairy product

EXPERIMENTAL

The product will be taken for 14 days

Other: Dairy product

Aequasyal mouth spray medical device

ACTIVE COMPARATOR

The spray will be taken for 14 days

Device: Aequasyal mouth spray

Interventions

Dairy product OTHER

Dairy products are given to patients with the instruction to eat as many products as necessary to provide them with some relief (within a limit of 6 per day) for 14 days

Dairy product

Aequasyal mouth spray DEVICE

The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days

Aequasyal mouth spray medical device

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years old
• Patients seen in the psychiatry department requiring the prescription of psychotropic drugs (antidepressants anxiolytics) for over 6 weeks
• Patients complaining of xerostomia
• Patients having not taken a palliative therapy against xerostomia for at least 2 weeks
• Patients having signed a free and informed consent form
• Patients affiliated to a social security system

You may not qualify if:

• Patients suffering from psychotic illness
• Patients suffering from Sjogren's syndrome
• Patients having been treated by radiation therapy for head or neck cancer
• Patients having stopped a palliative therapy against xerostomia for less than 2 weeks
• Patients under 18
• Pregnant or Breastfeeding women
• Incapacitated adults
• Patients placed under tutorship or curatorship
• Patients under judicial protection
• Patients suffering from milk allergy or lactose intolerance

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Ecole Nationale de l'Industrie Laitière (ENIL): collaborator
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

CHU de Besancon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Xerostomia

Interventions

Dairy Products

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nazim NEKROUF, MD

  Besancon University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazim NEKROUF, MD

CONTACT

0033.3.81.21.82.75; n1nekrouf@chu-besancon.fr

Gaelle Brunotte, PharmD

CONTACT

gbrunotte@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: March 11, 2016
• Study Start: September 13, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

FR (1)