ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients

NCT06733948 | Recruiting Phase 2

• 1 other identifier: NPC Dental Stent
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 1.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.
2. 2.Evaluate and compare tumor response, overall survival, and failure-free survival between chemoradiation plus dental stent group and chemoradiation group.
3. 3.Analyze dosimetric parameters of taste bud bearing tongue mucosa, ipsilateral/ contralateral parotid and submandibular glands extracted from RT plans and correlate with taste impair

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal cancer; dental stent; nasopharyngeal carcinoma; chemogustrometry; taste test; chemoradiation

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Acute toxicities (other than taste) graded according to NCI CTCAE V5.0

  From baseline to 52 weeks post-RT

• Acute toxicities (other than taste) 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

  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

  From enrollment to 52 weeks after the end of treatment

• Dosimetry doses measured in Gy

  From the first radiation therapy to the end of the radiation therapy at 6-7 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Radiotherapy with dental stent +/- Concurrent systemic therapy

Device: Dental stent

Control

OTHER

Radiotherapy with no dental stent +/- Concurrent systemic therapy

Other: No dental stent

Interventions

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.

Arm 1

No dental stent OTHER

No dental stent used during chemoradiation treatment

Control

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Singapore Institute of Food and Biotechnology Innovation: collaborator

Study Sites (2)

Singapore Institute of Food and Biotechnology Innovation

Singapore, 117599, Singapore

NOT YET RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Timothy Cheo, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shing Fung Lee, MBBS

CONTACT

+6567726392; leesf@nuhs.edu.sg

Fatin Aliyah Binte Hussin, BSc

CONTACT

+6567723079; fatin_hussin@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: December 13, 2024
• Study Start: September 24, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

SG (2)