Cancer of Head NeckNCT03035825
Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients
A study testing Oral moisturizing jelly and Artificial saliva in people with Cancer of Head Neck and Radiation-Induced Xerostomia, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
Trial summary
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer of Head Neck, Radiation-Induced Xerostomia, Dry Mouth
- What is being tested?
- Oral moisturizing jelly and Artificial saliva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2017to 30 Jan 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
- If undergoing chemotherapy, have to finish for at least 2 weeks.
- Have subjective dry mouth scores at least 3
- Can perform oral intake without aspiration
- Can communicate well
Who cannot join
- Has recurrence of cancer
- Has mucositis more than grade 1
- Has oral infection such as candidiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
Read the detailed description
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.
- Conditions
- Cancer of Head Neck, Radiation-Induced Xerostomia, Dry Mouth
- Being tested
- Oral moisturizing jelly, Artificial saliva
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral moisturizing jellyDietary supplement
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
Artificial salivaOther
Also called Dry mouth gel
A non-edible oral lubricating gel for dry mouth patients
| Study group | Role | What they receive |
|---|---|---|
| Oral Moisturizing Jelly | Experimental | Daily intake of oral moisturizing jelly 5 times/day for two months Receives: Dietary Supplement: Oral moisturizing jelly |
| Artificial saliva | Active comparator | Daily use of non-edible oral lubricating gel 5 times/day for two months Receives: Other: 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 compared to baseline
Evaluation of subjective dry mouth score by questionaire
Measured: Baseline, 1 and 2 months after intervention
Secondary outcomes (9)
Changes in objective dry mouth score compared to baseline
Evaluation of objective dry mouth score by oral examination
Measured: Baseline, 1 and 2 months after intervention
Changes in salivary pH compared to baseline
Evaluation of salivary pH using pH indicator paper
Measured: Baseline, 1 and 2 months after intervention
Changes in salivary buffering capacity compared to baseline
Evaluation of salivary buffering capacity using a commercial saliva check buffer kit
Measured: Baseline, 1 and 2 months after intervention
Changes in Candidal counts of saliva compared to baseline
Evaluation of number of fungal colonies of Candida spp. in saliva by culture
Measured: Baseline, 1 and 2 months after intervention
Changes in energy intake compared to baseline
Evaluation of energy intake per day using dietary record and analysis
Measured: Baseline, 1 and 2 months after intervention
Changes in subjective swallow ability compared to baseline
Evaluation of subjective swallow ability using EAT-10 questionaire
Measured: Baseline, 1 and 2 months after intervention
Changes in appetite compared to baseline
Evaluation of appetite using questionnaire
Measured: Baseline, 1 and 2 months after intervention
Changes in tolerance to spicy food
Evaluation of tolerance to spicy food using questionnaire
Measured: Baseline, 1 and 2 months after intervention
Changes in umami taste recognition threshold compared to baseline
Evaluation of umami taste recognition threshold using filter paper disc method
Measured: Baseline, 1 and 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Innovation Foundation Under Royal Patronage
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Aroonwan Lam-ubol, DDS, PhD, Principal investigator, Srinakarinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035825
- Sponsor's protocol ID
- DIF-05
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lam-Ubol A, Matangkasombut O, Trachootham D, Tarapan S, Sattabanasuk V, Talungchit S, Paemuang W, Phonyiam T, Chokchaitam O, Mungkung OO. Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial. Clin Oral Investig. 2021 Apr;25(4):1815-1827. doi: 10.1007/s00784-020-03484-1. Epub 2020 Aug 10.
PubMed 32779011Nuchit S, Lam-Ubol A, Paemuang W, Talungchit S, Chokchaitam O, Mungkung OO, Pongcharoen T, Trachootham D. Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2817-2828. doi: 10.1007/s00520-019-05132-1. Epub 2019 Nov 15.
PubMed 31732852
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia
- ClinicalTrials.gov ID
- NCT03035825
- Acronym / sponsor ID
- DIF-05
- Conditions
- Cancer of Head Neck, Radiation-Induced Xerostomia, Dry Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dental Innovation Foundation Under Royal PatronageUniversity, hospital or other
- Collaborators
- Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 30 Jan 2017 (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.
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
Detailed description
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Moisturizing Jelly | Experimental | Dietary Supplement: Oral moisturizing jellyDaily intake of oral moisturizing jelly 5 times/day for two months |
| Artificial saliva | Active comparator | Other: Artificial salivaDaily use of non-edible oral lubricating gel 5 times/day for two months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
- If undergoing chemotherapy, have to finish for at least 2 weeks.
- Have subjective dry mouth scores at least 3
- Can perform oral intake without aspiration
- Can communicate well
Key exclusion criteria (3 listed)
- Has recurrence of cancer
- Has mucositis more than grade 1
- Has oral infection such as candidiasis
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 |
|---|---|---|
| Oral moisturizing jellyGel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth | Dietary supplement | Oral Moisturizing Jelly |
| Artificial salivaAlso: Dry mouth gelA non-edible oral lubricating gel for dry mouth patients | Other | Artificial saliva |
Primary outcome
Changes in subjective dry mouth score compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Evaluation of subjective dry mouth score by questionaire
9 secondary outcomes
Changes in objective dry mouth score compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in salivary pH compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in salivary buffering capacity compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in Candidal counts of saliva compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in energy intake compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in subjective swallow ability compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in appetite compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
Changes in tolerance to spicy food
Time frame: Baseline, 1 and 2 months after intervention
Changes in umami taste recognition threshold compared to baseline
Time frame: Baseline, 1 and 2 months after intervention
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 8 Feb 2019.
- Derived from this study: PubMed 32779011Lam-Ubol A, Matangkasombut O, Trachootham D, Tarapan S, Sattabanasuk V, Talungchit S, Paemuang W, Phonyiam T, Chokchaitam O, Mungkung OO. Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial. Clin Oral Investig. 2021 Apr;25(4):1815-1827. doi: 10.1007/s00784-020-03484-1. Epub 2020 Aug 10.
- Derived from this study: PubMed 31732852Nuchit S, Lam-Ubol A, Paemuang W, Talungchit S, Chokchaitam O, Mungkung OO, Pongcharoen T, Trachootham D. Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2817-2828. doi: 10.1007/s00520-019-05132-1. Epub 2019 Nov 15.
- Individual participant dataSharing planned: No
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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 principal investigator
Srinakarinwirot 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 Oral moisturizing jelly and Artificial saliva in people with Cancer of Head Neck and Radiation-Induced Xerostomia, 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 5 inclusion and 3 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 8 Feb 2019. 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 compared to baseline (time frame: Baseline, 1 and 2 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035825, which also lists 2 linked publications.
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 8 Feb 2019.