XerostomiaNCT01915966
Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients
A study testing Cardamom, ginger and orange juice gelatin and Camomile infusion with lemon juice in people with Xerostomia and Salivary Gland Diseases, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Xerostomia, Salivary Gland Diseases, Mouth Diseases
- What is being tested?
- Cardamom, ginger and orange juice gelatin and Camomile infusion with lemon juice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Cardamom, ginger and orange juice gelatin, Camomile infusion with lemon juice
- Medical subject headings
- Xerostomia, Salivary Gland Diseases, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardamom, ginger and orange juice gelatinDietary 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 juiceDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Cardamom, ginger and orange juice gelatin | Experimental | Dietary Supplement Receives: Dietary Supplement: Cardamom, ginger and orange juice gelatin |
| Camomile infusion with lemon juice | Active comparator | Dietary Supplement Receives: Dietary Supplement: Camomile infusion with lemon juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
Measured: At end of treatment (1 week )
Secondary outcomes (3)
Objective signs of xerostomia
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.
Measured: At end of treatment (1 week )
Scale of subjective assessment of salival disfunction (Pai 2001).
Measured: At end of treatment (1 week )
Treatment acceptability
Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.
Measured: At end of treatment (1 week )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Collaborators
- Mutuam
- Responsible party
- Principal investigator, Teresa Peris, Mutuam
- Investigators
- Teresa Peris, RN, Principal investigator, Mutuam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915966
- Sponsor's protocol ID
- FICE-MUT-02-1933-2013
- Status last verified
- Feb 2014
- First submitted
- 30 Jul 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01915966
- Acronym / sponsor ID
- FICE-MUT-02-1933-2013
- Conditions
- Xerostomia, Salivary Gland Diseases, Mouth Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Collaborators
- Mutuam
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardamom, ginger and orange juice gelatin | Experimental | Dietary Supplement: Cardamom, ginger and orange juice gelatinDietary Supplement |
| Camomile infusion with lemon juice | Active comparator | Dietary Supplement: Camomile infusion with lemon juiceDietary Supplement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardamom, ginger and orange juice gelatinPatients 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 | Cardamom, ginger and orange juice gelatin |
| Camomile infusion with lemon juicePatients 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. | Dietary supplement | Camomile infusion with lemon juice |
Primary outcome
Scale of self-perceived mouth dryness (0=not at all, 10=very dry)
Time frame: At end of treatment (1 week )
3 secondary outcomes
Objective signs of xerostomia
Time frame: At end of treatment (1 week )
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Peris, RN principal investigator
Mutuam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardamom, ginger and orange juice gelatin and Camomile infusion with lemon juice in people with Xerostomia and Salivary Gland Diseases, run by Fundacio Salut i Envelliment UAB at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of self-perceived mouth dryness (0=not at all, 10=very dry) (time frame: At end of treatment (1 week )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.