Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients
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|ClinicalTrials.gov Identifier: NCT01915966|
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : February 11, 2014
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 or disease||Intervention/treatment||Phase|
|Xerostomia Salivary Gland Diseases Mouth Diseases||Dietary Supplement: Cardamom, ginger and orange juice gelatin Dietary Supplement: Camomile infusion with lemon juice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2013|
|Actual Primary Completion Date :||January 2014|
Experimental: Cardamom, ginger and orange juice gelatin
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: 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.
- Scale of self-perceived mouth dryness (0=not at all, 10=very dry) [ Time Frame: At end of treatment (1 week ) ]
- 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.
- Scale of subjective assessment of salival disfunction (Pai 2001). [ Time Frame: At end of treatment (1 week ) ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915966
|Principal Investigator:||Teresa Peris, RN||Mutuam|