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

Primary Purpose

Xerostomia, Salivary Gland Diseases, Mouth Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cardamom, ginger and orange juice gelatin
Camomile infusion with lemon juice
Sponsored by
Fundacio Salut i Envelliment UAB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • MUTUAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardamom, ginger and orange juice gelatin

Camomile infusion with lemon juice

Arm Description

Dietary Supplement

Dietary Supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Scale of subjective assessment of salival disfunction (Pai 2001).
Treatment acceptability
Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.

Full Information

First Posted
July 30, 2013
Last Updated
February 10, 2014
Sponsor
Fundacio Salut i Envelliment UAB
Collaborators
Mutuam
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1. Study Identification

Unique Protocol Identification Number
NCT01915966
Brief Title
Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio Salut i Envelliment UAB
Collaborators
Mutuam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Salivary Gland Diseases, Mouth Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardamom, ginger and orange juice gelatin
Arm Type
Experimental
Arm Description
Dietary Supplement
Arm Title
Camomile infusion with lemon juice
Arm Type
Active Comparator
Arm Description
Dietary Supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Cardamom, ginger and orange juice gelatin
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Camomile infusion with lemon juice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
Time Frame
At end of treatment (1 week )
Secondary Outcome Measure Information:
Title
Objective signs of xerostomia
Description
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.
Time Frame
At end of treatment (1 week )
Title
Scale of subjective assessment of salival disfunction (Pai 2001).
Time Frame
At end of treatment (1 week )
Title
Treatment acceptability
Description
Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.
Time Frame
At end of treatment (1 week )

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Peris, RN
Organizational Affiliation
Mutuam
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUTUAM
City
Barcelona
Country
Spain

12. IPD Sharing Statement

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

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