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Completed

NCT Number: NCT01915966

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

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.

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUTUAM

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: At end of treatment (1 week )

Secondary outcomes

  1. Objective signs of xerostomia

    Time frame: At end of treatment (1 week )

    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.

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

    Time frame: At end of treatment (1 week )

  3. Treatment acceptability

    Time frame: At end of treatment (1 week )

    Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.

Sponsors and collaborators

Lead sponsor

Fundacio Salut i Envelliment UAB

Other

Collaborators

  • Mutuam

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
First posted
Aug 5, 2013
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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