Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient-assessed taste impairment using the QLQ-HN43 module
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed with histologically confirmed non-keratinizing NPC.
- •Patients with Tumours staged as T1-4N+/TxN0-
- •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
- •Able to provide informed consent
- •Induction chemotherapy before radical chemoradiation to nasopharynx and neck is permissible if no disease progression after induction chemotherapy
排除标准
- •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.
研究组 & 干预措施
Arm 1
Radiotherapy with dental stent +/- Concurrent systemic therapy
干预措施: Dental stent (Device)
Control
Radiotherapy with no dental stent +/- Concurrent systemic therapy
干预措施: No dental stent (Other)
结局指标
主要结局
Patient-assessed taste impairment using the QLQ-HN43 module
时间窗: 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.
Objective testing using test strips
时间窗: 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.
Taste impairment assessed on NCI CTCAE version 5.0 grading
时间窗: 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
时间窗: 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
次要结局
- 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)