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

NCT01915966 | Completed

• 1 other identifier: FICE-MUT-02-1933-2013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Salivary Gland Diseases; Mouth Diseases

Outcome Measures

Primary Outcomes (1)

• Scale of self-perceived mouth dryness (0=not at all, 10=very dry)

  At end of treatment (1 week )

Secondary Outcomes (3)

• Objective signs of xerostomia

  At end of treatment (1 week )

• Scale of subjective assessment of salival disfunction (Pai 2001).

  At end of treatment (1 week )

• Treatment acceptability

  At end of treatment (1 week )

Study Arms (2)

Cardamom, ginger and orange juice gelatin

EXPERIMENTAL

Dietary Supplement

Dietary Supplement: Cardamom, ginger and orange juice gelatin

Camomile infusion with lemon juice

ACTIVE COMPARATOR

Dietary Supplement

Dietary Supplement: Camomile infusion with lemon juice

Interventions

Cardamom, ginger and orange juice gelatin DIETARY_SUPPLEMENT

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

Cardamom, ginger and orange juice gelatin

Camomile infusion with lemon juice DIETARY_SUPPLEMENT

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.

Camomile infusion with lemon juice

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacio Salut i Envelliment UAB: lead
• Mutuam: collaborator

Study Sites (1)

MUTUAM

Barcelona, Barcelona, Spain

Location

MeSH Terms

Conditions

Xerostomia; Salivary Gland Diseases; Mouth Diseases

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Teresa Peris, RN

  Mutuam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Palliativa Care Nurse

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 5, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

ES (1)