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

NCT ID: NCT01915966

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

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.

Conditions

Xerostomia; Salivary Gland Diseases; Mouth Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardamom, ginger and orange juice gelatin

Dietary Supplement

Group Type: EXPERIMENTAL

Cardamom, ginger and orange juice gelatin

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Camomile infusion with lemon juice

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mutuam

OTHER

Sponsor Role: collaborator

Fundacio Salut i Envelliment UAB

OTHER

Sponsor Role: lead

Responsible Party

Teresa Peris

Palliativa Care Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Peris, RN

Role: PRINCIPAL_INVESTIGATOR

Mutuam

Locations

MUTUAM

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

FICE-MUT-02-1933-2013

Identifier Type: -

Identifier Source: org_study_id