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

Xerostomia Clinical Trial

Official title:

Randomized Clinical Trial of a Ginger and Cardamom Gelatin Compared to a Camomile and Lemon Juice Infusion in Control of Xerostomy in Terminally Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915966
• Other study ID #: FICE-MUT-02-1933-2013
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: February 10, 2014
• Start date: April 2013

Study information

• Verified date: February 2014
• Source: Fundacio Salut i Envelliment UAB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mouth Diseases
• Salivary Gland Diseases
• Xerostomia

Intervention

Dietary Supplement:
• Cardamom, ginger and orange juice gelatin
Patients will receive the recipe of the gelatin, with detailed instructions to prepare it at home, and the necessary ingredients for the gelatin. If necessary, they will be helped in the preparation of an initial batch that should last for one week of treatment. Patients will be instructed to consume the gelatin candy as necessary to alleviate the dry mouth sensation
• Camomile infusion with lemon juice
Patients will receive instructions to prepare the infusion at home, and the necessary ingredients. Patients will be instructed to ingest the infusion as necessary to alleviate the dry mouth sensation.

Locations

Country	Name	City	State
Spain	MUTUAM	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Salut i Envelliment UAB	Mutuam

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale of self-perceived mouth dryness (0=not at all, 10=very dry)		At end of treatment (1 week )	No
Secondary	Objective signs of xerostomia	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.	At end of treatment (1 week )	No
Secondary	Scale of subjective assessment of salival disfunction (Pai 2001).		At end of treatment (1 week )	No
Secondary	Treatment acceptability	Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.	At end of treatment (1 week )	No