Nasopharyngeal CarcinomaPhase 2NCT06733948
ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients
A Phase 2 study testing Dental stent and No dental stent in people with Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
Primary objective: Evaluate and compare incidence of acute and long-term taste dysfunction in chemoradiation plus dental stent group vs. chemoradiation group, using objective-measured taste strip test, and patient-reported taste ability and toxicity. Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Dental stent and No dental stent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSingapore
- Study dates
- 24 Sep 2024to May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed with histologically confirmed non-keratinizing NPC.
- Patients with Tumours staged as T1-4N+/TxN0-3.
- No sign of distant metastasis (M0).
- Satisfactory performance status (i.e., Karnofsky Performance Status ≥ 70 or ECOG < 2)
- Age 21 years or older.
- Adequate bone marrow function by peripheral blood counts as demonstrated by the following laboratory values:
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- ≥ 3 × 109/L leucocytes
- ≥ 1.5 × 109/L neutrophils
- ≥ 9 g/dL of haemoglobin, and
- ≥ 100 × 109/L platelets.
- Normal liver function demonstrated by the following laboratory values:
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) concentrations of < 1.5x upper limit of normal (ULN)
- Alkaline phosphatase (ALP) concentration < 2.5x ULN
- Bilirubin < ULN.
- Renal function: Creatinine clearance at ≥60 mL/min
- Able to provide informed consent
- 7. Induction chemotherapy before radical chemoradiation to nasopharynx and neck is permissible if no disease progression after induction chemotherapy
Who cannot join
- Edentulous patients
- Extensive crown/ implant work to the teeth
- Patients having basaloid squamous cell carcinoma or WHO keratinizing squamous cell carcinoma.
- Patients who suffered from previous malignancies, except adequately treated basal cell or squamous cell skin cancer, and in-situ cervical cancer.
- Received RT previously (except for non-melanomatous skin cancers outside the intended RT treatment area)
- Patients who received previous surgery (except diagnostic) or chemotherapy for the primary tumours or lymph nodes or history of glossectomy.
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- Patient who had a prior diagnosis of diseases effecting saliva secretion or causing salivary glands impairment (i.e., Sjogren's syndrome, iodine cancer treatment), had a reported history of abnormal sense of taste or eating disorders.
- Current heavy smokers (smoke > 1 pack/day) or previous heavy smokers (stopped smoking less than 2 years and had smoked > 1 pack/day).
- Patients suffering from any severe intercurrent disease, which may incur unacceptable risk or negatively affect trial compliance. For example, unstable cardiac disease necessitating treatment, chronic hepatitis renal disease, poorly controlled diabetes (fasting plasma glucose greater 1.5x upper limit of normal), and emotional disturbance.
- Pregnant or lactating women.
- Inability to attend the full course of RT or planned follow-up/survey responses.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Not yet recruiting
Singapore Institute of Food and Biotechnology Innovation
Singapore, 117599
Pey Sze Teo, PhD, teo_pey_sze@sifbi.a-star.edu.sg
- Recruiting
National University Hospital
Singapore, 119074
Fatin Aliyah Binte Hussin, BSc, +6567723079, fatin_hussin@nuhs.edu.sg
Qian Yee Chai, BSc, +6567723077, queenie_qy_chai@nuhs.edu.sg
About this study
Official title: Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial
Primary objective:
Evaluate and compare incidence of acute and long-term taste dysfunction in chemoradiation plus dental stent group vs. chemoradiation group, using objective-measured taste strip test, and patient-reported taste ability and toxicity.
Read more
Secondary objectives:
- Evaluate and compare incidence of acute and long-term toxicities (excluding taste) and patient-reported quality of life between chemoradiation plus dental stent group and chemoradiation group.
- Evaluate and compare tumor response, overall survival, and failure-free survival between chemoradiation plus dental stent group and chemoradiation group.
- Analyze dosimetric parameters of taste bud bearing tongue mucosa, ipsilateral/ contralateral parotid and submandibular glands extracted from RT plans and correlate with taste impair
Read the detailed description
This study is a phase II randomized control trial assessing the efficacy of adding a dental stent for sparing the taste bud and protect the taste sensation in NPC patients undergoing chemoradiation. The enrolled participants will be randomized to add a personalized dental stent during the radical chemoradiation to nasopharynx and neck using IMRT technique. Chemoradiation must begin no later than 4 weeks from the time of recruitment, although treatment as early as possible is highly encouraged.
A total of 50 patients (25 patients each arm) will be accrued to assess the potential benefit and safety of the said dental stent to standard chemoradiation.
All participants will be followed up as follows:
- One visit before induction chemotherapy (if any)
- One visit within 6 weeks before RT
- Weekly during treatment and at the end of treatment (6-7 visits depending on treatment schedule),
- One visit at 4 weeks post treatment (with +/-2 weeks window period)
- One visit at 12 weeks post treatment (with +/- 4 weeks window period)
- One visit at 26 weeks post treatment (with +/-4 weeks window period) and
- One visit at 52 weeks post treatment (with +/-4 weeks window period) to review their general condition, toxicities, and long-term treatment efficacy and safety profile.
The assessment of taste sensation using subjective questionnaires, alongside objective measures using taste strip tests are performed at baseline, the 12 weeks post treatment follow up and at the 52 weeks post treatment follow up visits.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Dental stent, No dental stent
- Keywords
- nasopharyngeal cancer, dental stent, nasopharyngeal carcinoma, chemogustrometry, taste test, chemoradiation
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental stentDevice
Dental stent is personalised device for tongue depressing and immobilisation during RT. The aims are to reduce unnecessary RT doses to adjacent non-target healthy tissue, including the tongue, adjacent oral mucosa, parotid glands/ submandibular glands, and temporomandibular joints. Dentists will take impression of the teeth on moulds, and measure the height to raise the bite, the stent is then fabricated as methyl methacrylate resin in the dental laboratory. The resin base extends to the tongue and a flat plate depresses the tongue. This device will be placed before each RT fraction.
No dental stentOther
No dental stent used during chemoradiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Radiotherapy with dental stent +/- Concurrent systemic therapy Receives: Device: Dental stent |
| Control | Other | Radiotherapy with no dental stent +/- Concurrent systemic therapy Receives: Other: No dental stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-assessed taste impairment using the QLQ-HN43 module
Patient-assessed taste impairment measured on 4-point verbal rating scale, ranging from none to severe using the QLQ-HN43 module.
Measured: From baseline to 52 weeks post-RT
Taste impairment assessed on NCI CTCAE version 5.0 grading
Taste alterations (dysgeusia) will be graded between Grades 0 to 2.
Measured: From baseline to 52 weeks post RT
Taste impairment measured on the STTA scale
The STTA scale modified from the Late Effects Normal Tissue/Subjective Objective Management Analytic is a scoring system for taste acuity ranging from Grades 0 to 4
Measured: From baseline to 52 weeks post-RT
Objective testing using test strips
Taste strips are a validated approach to assess taste ability for the five primary taste modalities - sweet, sour, salty, bitter, and umami.
Measured: From baseline to 52 weeks post-RT
Secondary outcomes (5)
Acute toxicities (other than taste) graded according to NCI CTCAE V5.0
Other toxicities experienced by the patients during treatment. For example, dermatitis, mucositis, dry mouth will be graded according to the CTCAE V5.0 scales.
Measured: From baseline to 52 weeks post-RT
Acute toxicities (other than taste) graded according to the STTA scale
Other toxicities experienced by the patients during treatment will be graded according to the STTA scale.
Measured: From baseline to 52 weeks post-RT
Patient-reported QoLs between the 2 groups according to EORTC modules QLQ-C30 and QLQ-HN43
EORTC QLQ-C30 and specific module for head and neck EORTC QLQ-HN43 will be used.
Measured: From enrollment to 52 weeks after the end of treatment
OS, FFS, distant FFS, and locoregional FFS between the 2 groups measured in years and months
FFS was defined as the interval between randomization and distant failure, locoregional failure, or death from any cause, whichever happened first. OS was defined as the interval from randomization to death from any cause. The distant FFS was defined as the interval from randomization to the first distant metastasis. The locoregional FFS was defined as the interval from randomization to the first local or regional recurrence.
Measured: From enrollment to 52 weeks after the end of treatment
Dosimetry doses measured in Gy
The mean, minimum, and maximum doses measured in gray (Gy) to the taste bud bearing tongue mucosa, the ipsilateral- and contralateral parotid and submandibular glands are extracted from the RT plans.
Measured: From the first radiation therapy to the end of the radiation therapy at 6-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start24 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned in a 1:1 ratio to Arm 1 and Arm 2. A web-based number generator will be used to generate random allocation lists using block sizes n =4 each. The treatment assignation is not masked. Subjects in the intervention group will receive the addition of dental stent to their radical concurrent chemoradiation, while those in the control group will receive radical concurrent chemoradiation with no dental stent. The process is not blinded to patient and investigators.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Responsible party
- Sponsor
- Investigators
- Timothy Cheo, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733948
- Sponsor's protocol ID
- NPC Dental Stent
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06733948
- Acronym / sponsor ID
- NPC Dental Stent
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal cancer, dental stent, nasopharyngeal carcinoma, chemogustrometry, taste test, chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- 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.
Primary objective:
Evaluate and compare incidence of acute and long-term taste dysfunction in chemoradiation plus dental stent group vs. chemoradiation group, using objective-measured taste strip test, and patient-reported taste ability and toxicity.
Secondary objectives:
- Evaluate and compare incidence of acute and long-term toxicities (excluding taste) and patient-reported quality of life between chemoradiation plus dental stent group and chemoradiation group.
- Evaluate and compare tumor response, overall survival, and failure-free survival between chemoradiation plus dental stent group and chemoradiation group.
- Analyze dosimetric parameters of taste bud bearing tongue mucosa, ipsilateral/ contralateral parotid and submandibular glands extracted from RT plans and correlate with taste impair
Detailed description
This study is a phase II randomized control trial assessing the efficacy of adding a dental stent for sparing the taste bud and protect the taste sensation in NPC patients undergoing chemoradiation. The enrolled participants will be randomized to add a personalized dental stent during the radical chemoradiation to nasopharynx and neck using IMRT technique. Chemoradiation must begin no later than 4 weeks from the time of recruitment, although treatment as early as possible is highly encouraged.
A total of 50 patients (25 patients each arm) will be accrued to assess the potential benefit and safety of the said dental stent to standard chemoradiation.
All participants will be followed up as follows:
- One visit before induction chemotherapy (if any)
- One visit within 6 weeks before RT
- Weekly during treatment and at the end of treatment (6-7 visits depending on treatment schedule),
- One visit at 4 weeks post treatment (with +/-2 weeks window period)
- One visit at 12 weeks post treatment (with +/- 4 weeks window period)
- One visit at 26 weeks post treatment (with +/-4 weeks window period) and
- One visit at 52 weeks post treatment (with +/-4 weeks window period) to review their general condition, toxicities, and long-term treatment efficacy and safety profile.
The assessment of taste sensation using subjective questionnaires, alongside objective measures using taste strip tests are performed at baseline, the 12 weeks post treatment follow up and at the 52 weeks post treatment follow up visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned in a 1:1 ratio to Arm 1 and Arm 2. A web-based number generator will be used to generate random allocation lists using block sizes n =4 each. The treatment assignation is not masked. Subjects in the intervention group will receive the addition of dental stent to their radical concurrent chemoradiation, while those in the control group will receive radical concurrent chemoradiation with no dental stent. The process is not blinded to patient and investigators.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Dental stentRadiotherapy with dental stent +/- Concurrent systemic therapy |
| Control | Other | Other: No dental stentRadiotherapy with no dental stent +/- Concurrent systemic therapy |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients newly diagnosed with histologically confirmed non-keratinizing NPC.
- Patients with Tumours staged as T1-4N+/TxN0-3.
- No sign of distant metastasis (M0).
- Satisfactory performance status (i.e., Karnofsky Performance Status ≥ 70 or ECOG < 2)
- Age 21 years or older.
Key exclusion criteria (11 listed)
- Edentulous patients
- Extensive crown/ implant work to the teeth
- Patients having basaloid squamous cell carcinoma or WHO keratinizing squamous cell carcinoma.
- Patients who suffered from previous malignancies, except adequately treated basal cell or squamous cell skin cancer, and in-situ cervical cancer.
- Received RT previously (except for non-melanomatous skin cancers outside the intended RT treatment area)
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 |
|---|---|---|
| Dental stentDental stent is personalised device for tongue depressing and immobilisation during RT. The aims are to reduce unnecessary RT doses to adjacent non-target healthy tissue, including the tongue, adjacent oral mucosa, parotid glands/ submandibular glands, and temporomandibular joints. Dentists will take impression of the teeth on moulds, and measure the height to raise the bite, the stent is then fabricated as methyl methacrylate resin in the dental laboratory. The resin base extends to the tongue and a flat plate depresses the tongue. This device will be placed before each RT fraction. | Device | Arm 1 |
| No dental stentNo dental stent used during chemoradiation treatment | Other | Control |
Primary outcome
Patient-assessed taste impairment using the QLQ-HN43 module
Time frame: From baseline to 52 weeks post-RT
Patient-assessed taste impairment measured on 4-point verbal rating scale, ranging from none to severe using the QLQ-HN43 module.
Taste impairment assessed on NCI CTCAE version 5.0 grading
Time frame: From baseline to 52 weeks post RT
Taste alterations (dysgeusia) will be graded between Grades 0 to 2.
Taste impairment measured on the STTA scale
Time frame: From baseline to 52 weeks post-RT
The STTA scale modified from the Late Effects Normal Tissue/Subjective Objective Management Analytic is a scoring system for taste acuity ranging from Grades 0 to 4
Objective testing using test strips
Time frame: From baseline to 52 weeks post-RT
Taste strips are a validated approach to assess taste ability for the five primary taste modalities - sweet, sour, salty, bitter, and umami.
5 secondary outcomes
Acute toxicities (other than taste) graded according to NCI CTCAE V5.0
Time frame: From baseline to 52 weeks post-RT
Acute toxicities (other than taste) graded according to the STTA scale
Time frame: From baseline to 52 weeks post-RT
Patient-reported QoLs between the 2 groups according to EORTC modules QLQ-C30 and QLQ-HN43
Time frame: From enrollment to 52 weeks after the end of treatment
OS, FFS, distant FFS, and locoregional FFS between the 2 groups measured in years and months
Time frame: From enrollment to 52 weeks after the end of treatment
Dosimetry doses measured in Gy
Time frame: From the first radiation therapy to the end of the radiation therapy at 6-7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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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.
Timothy Cheo, MBBS principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dental stent and No dental stent in people with Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 2 sites in Singapore.
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 17 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shing Fung Lee, MBBS (+6567726392, leesf@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-assessed taste impairment using the QLQ-HN43 module (time frame: From baseline to 52 weeks post-RT). The study lists 4 primary outcomes in all. 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 13 Dec 2024.