Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Singapore Institute of Food and Biotechnology Innovation | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Radiotherapy with dental stent +/- Concurrent systemic therapy |
|
| Control | Other | Radiotherapy with no dental stent +/- Concurrent systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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. | From baseline to 52 weeks post-RT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 52 weeks post-RT |
| Acute toxicities (other than taste) graded according to the STTA scale |
Not provided
Inclusion Criteria:
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:
Normal liver function demonstrated by the following laboratory values:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shing Fung Lee, MBBS | Contact | +6567726392 | leesf@nuhs.edu.sg | |
| Fatin Aliyah Binte Hussin, BSc | Contact | +6567723079 | fatin_hussin@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Cheo, MBBS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Institute of Food and Biotechnology Innovation | Not yet recruiting | Singapore | 117599 | Singapore |
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| No dental stent | Other | No dental stent used during chemoradiation treatment |
|
Other toxicities experienced by the patients during treatment will be graded according to the STTA scale. |
| 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. | 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. | 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. | From the first radiation therapy to the end of the radiation therapy at 6-7 weeks |
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
|
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |