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

This study has been completed.
Sponsor:
Collaborator:
Mutuam
Information provided by (Responsible Party):
Teresa Peris, Mutuam
ClinicalTrials.gov Identifier:
NCT01915966
First received: July 30, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Dietary Supplement: Cardamom, ginger and orange juice gelatin
Dietary Supplement: Camomile infusion with lemon juice

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

Resource links provided by NLM:


Further study details as provided by Fundacio Institut Catala de l'Envelliment:

Primary Outcome Measures:
  • Scale of self-perceived mouth dryness (0=not at all, 10=very dry) [ Time Frame: At end of treatment (1 week ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective signs of xerostomia [ Time Frame: At end of treatment (1 week ) ] [ Designated as safety issue: No ]
    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). [ Time Frame: At end of treatment (1 week ) ] [ Designated as safety issue: No ]
  • Treatment acceptability [ Time Frame: At end of treatment (1 week ) ] [ Designated as safety issue: No ]
    Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.


Enrollment: 32
Study Start Date: April 2013
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardamom, ginger and orange juice gelatin
Dietary Supplement
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
Active Comparator: Camomile infusion with lemon juice
Dietary Supplement
Dietary Supplement: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915966

Locations
Spain
MUTUAM
Barcelona, Spain
Sponsors and Collaborators
Fundacio Institut Catala de l'Envelliment
Mutuam
Investigators
Principal Investigator: Teresa Peris, RN Mutuam
  More Information

No publications provided

Responsible Party: Teresa Peris, Palliativa Care Nurse, Mutuam
ClinicalTrials.gov Identifier: NCT01915966     History of Changes
Other Study ID Numbers: FICE-MUT-02-1933-2013
Study First Received: July 30, 2013
Last Updated: February 10, 2014
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Mouth Diseases
Salivary Gland Diseases
Xerostomia
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014