Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients

Not Applicable

Completed

• Conditions: Xerostomia; Salivary Gland Diseases; Mouth Diseases
• Interventions: Dietary Supplement: Cardamom, ginger and orange juice gelatin; Dietary Supplement: Camomile infusion with lemon juice

• Registration Number: NCT01915966
• Lead Sponsor: Fundacio Salut i Envelliment UAB

Brief Summary

Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.

The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Primary Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 18 years or older
• Receiving palliative care for terminall illness at MUTUAM PADES
• Complaining of dry mouth and should not have been treated for this problem
• Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so

Exclusion Criteria

• Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
• Oropharinx neoplasm treated with surgery or radiotherapy.
• Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
• Motor dysphagia causing coordination problems in swallowing.
• Life expectancy less than seven days (Last Days Situation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardamom, ginger and orange juice gelatin	Cardamom, ginger and orange juice gelatin	Dietary Supplement
Camomile infusion with lemon juice	Camomile infusion with lemon juice	Dietary Supplement

Primary Outcome Measures

Name	Time	Method
Scale of self-perceived mouth dryness (0=not at all, 10=very dry)	At end of treatment (1 week )

Secondary Outcome Measures

Name	Time	Method
Objective signs of xerostomia	At end of treatment (1 week )	Investigator will assess the presence of xerostomia signs through the assessment of 1) appearance and degree of dryness of tongue, buccal mucosa and lips, and 2)difficulties in speech derived from dry-mouth sensation in the patient.
Scale of subjective assessment of salival disfunction (Pai 2001).	At end of treatment (1 week )
Treatment acceptability	At end of treatment (1 week )	Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.

Trial Locations

Locations (1)

MUTUAM; 🇪🇸 Barcelona, Spain