Head and Neck CancerNCT01871155
Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients
A study testing Nutri-jelly in people with Head and Neck Cancer and Dysphagia, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Head and Neck Cancer, Dysphagia
- What is being tested?
- Nutri-jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Aug 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as head and neck cancer
- definitive or palliative radiotherapy treatment plan
- can communicate well
Who cannot join
- bleeding in the mouth
- respiratory distress
- psychiatric disorders
- radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer
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 Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.
Read the detailed description
- independent variable: continuous Nutri -jelly intake
- dependent variable (outcome): changes in health-related quality of life score
- Conditions
- Head and Neck Cancer, Dysphagia
- Being tested
- Nutri-jelly
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri-jellyDietary supplement
an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal
1 serving is considered as food supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutri-jelly along with radiotherapy | Experimental | Continuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy Receives: Dietary Supplement: Nutri-jelly |
| Radiotherapy only | No intervention | Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Health-related quality of life score
- Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks
- Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks
Measured: 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 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
- Dunyaporn Trachootham, DDS, PhD, Study chair, Faculty of Dentistry, Thammasat University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871155
- Sponsor's protocol ID
- DIF-01
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT01871155
- Acronym / sponsor ID
- DIF-01
- Conditions
- Head and Neck Cancer, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 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
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 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 a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.
Detailed description
- independent variable: continuous Nutri -jelly intake
- dependent variable (outcome): changes in health-related quality of life score
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutri-jelly along with radiotherapy | Experimental | Dietary Supplement: Nutri-jellyContinuous intake: orally take 1-3 boxes / day for at least 3 days/ week during radiotherapy |
| Radiotherapy only | No intervention | –Receive either definitive (total of 30-35 fractions) or palliative ( total of 10 fractions) radiotherapy with no continuous intake of Nutri-Jelly |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed as head and neck cancer
- definitive or palliative radiotherapy treatment plan
- can communicate well
Key exclusion criteria (4 listed)
- bleeding in the mouth
- respiratory distress
- psychiatric disorders
- radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer
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 |
|---|---|---|
| Nutri-jellyan edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement | Dietary supplement | Nutri-jelly along with radiotherapy |
Primary outcome
Changes in Health-related quality of life score
Time frame: 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy
* Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks * Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks
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 6 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.
Dunyaporn Trachootham, DDS, PhD study chair
Faculty of Dentistry, Thammasat University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri-jelly in people with Head and Neck Cancer and Dysphagia, 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 3 inclusion and 4 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 6 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 Health-related quality of life score (time frame: 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy). 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 6 Jun 2013.