Cancer of Head and NeckNCT01885065
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
A study testing Gel-based artificial saliva in people with Cancer of Head and Neck and Cancer, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cancer of Head and Neck, Cancer, Radiation-induced Xerostomia
- What is being tested?
- Gel-based artificial saliva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2012to Dec 2012
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems
Who cannot join
- mucositis more than grade 1
- cannot perform oral intake of gel-based artificial saliva eg. aspirate
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mahavachiralongkorn cancer hospital
Pathum Thani, Changwat Pathum Thani, 12110
About this study
Official title: Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
- Being tested
- Gel-based artificial saliva
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel-based artificial salivaOther
Also called Oral moisturizing jelly
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth.
Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gel-based artificial saliva | Experimental | Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks Receives: Other: Gel-based artificial saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective dry mouth score
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: baseline, 2 weeks and 4 weeks after intervention
Secondary outcomes (3)
Changes in objective dry mouth score
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: Baseline, 2 week and 4 weeks after the start date
Changes in salivary pH
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: Baseline, 2 weeks and 4 weeks after the start date
Changes in salivary buffering capacity
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: Baseline, 2 weeks and 4 weeks after the start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Innovation Foundation Under Royal Patronage
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Aroonwan Lam-ubol, DDS, PhD, Study chair, Faculty of Dentistry, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885065
- Sponsor's protocol ID
- DIF-02
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
- ClinicalTrials.gov ID
- NCT01885065
- Acronym / sponsor ID
- DIF-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dental Innovation Foundation Under Royal PatronageUniversity, hospital or other
- Collaborators
- Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Jun 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.
The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel-based artificial saliva | Experimental | Other: Gel-based artificial salivaContinuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems
Key exclusion criteria (2 listed)
- mucositis more than grade 1
- cannot perform oral intake of gel-based artificial saliva eg. aspirate
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 |
|---|---|---|
| Gel-based artificial salivaAlso: Oral moisturizing jellyGel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth. Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks. | Other | Gel-based artificial saliva |
Primary outcome
Changes in subjective dry mouth score
Time frame: baseline, 2 weeks and 4 weeks after intervention
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
3 secondary outcomes
Changes in objective dry mouth score
Time frame: Baseline, 2 week and 4 weeks after the start date
Changes in salivary pH
Time frame: Baseline, 2 weeks and 4 weeks after the start date
Changes in salivary buffering capacity
Time frame: Baseline, 2 weeks and 4 weeks after the start date
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 24 Jun 2013.
- Dental Innovation Foundation under Royal Patronage, His Majesty the King's Dental Service UnitLink provided by the sponsor.
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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.
Aroonwan Lam-ubol, DDS, PhD study chair
Faculty of Dentistry, Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel-based artificial saliva in people with Cancer of Head and Neck and Cancer, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
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 1 inclusion and 2 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 24 Jun 2013. 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 Thailand. 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?
Changes in subjective dry mouth score (time frame: baseline, 2 weeks and 4 weeks after intervention). 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 24 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.