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

Fundacio Salut i Envelliment UAB

Status: Completed

Conditions: Xerostomia; Mouth Diseases; Salivary Gland Diseases

Treatments: Dietary Supplement: Cardamom, ginger and orange juice gelatin; Dietary Supplement: Camomile infusion with lemon juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01915966

FICE-MUT-02-1933-2013

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Cardamom, ginger and orange juice gelatin

Experimental group

Description:

Dietary Supplement

Treatment:

Dietary Supplement: Cardamom, ginger and orange juice gelatin

Camomile infusion with lemon juice

Active Comparator group

Description:

Dietary Supplement

Treatment:

Dietary Supplement: Camomile infusion with lemon juice