Trial | NCT01915966  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
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.
Study Started
Apr 30
2013
Primary Completion
Jan 31
2014
Last Update
Feb 11
2014
Estimate

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

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.

Cardamom, ginger and orange juice gelatin Experimental

Dietary Supplement

Camomile infusion with lemon juice Active Comparator

Dietary Supplement

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).
No Results Posted