Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantitative taste perception
研究概览
简要总结
Taste changes, also called dysgeusia, affect 56-76% of patients with head and neck cancer treated with radiotherapy (with or without chemotherapy). These taste changes can make eating difficult, lead to weight loss, and reduce quality of life. Despite how common and impactful this problem is, there are very few standardized tools in speech-language therapy to assess or prevent it.
The aim of this study is to develop and test a preventive rehabilitation program for taste function. Eighty patients will be divided into two groups. The experimental group will receive a specific speech-language therapy intervention focused on taste for four weeks.
This intervention includes: salivary gland massage to stimulate saliva production, internal cryotherapy to keep the mouth moist and improve sensitivity, and taste training using four basic tastes at different intensity levels.
The effects of the intervention will be assessed before radiotherapy (with or without chemotherapy), at the end of treatment, and then 1, 3, 6 months, and 2 years after treatment. Assessment will include clinical tests, saliva measurements, taste detection and recognition tests, and quality-of-life questionnaires.
This clinical intervention aims to detect taste changes early and prevent them, helping to improve patients' comfort and nutrition.
详细描述
Dysgeusia affects 56-76% of head and neck cancer (HNC) patients undergoing (chemo)radiotherapy, impacting nutrition and quality of life. Standardized assessment and rehabilitation are limited. This study aims to develop and validate a 4-week prophylactic speech-language pathology protocol-including salivary gland massage, internal cryotherapy, and taste training-to preserve taste function. Eighty HNC patients undergoing (chemo)radiotherapy will be randomized to control (no intervention) or experimental (undergoing the 4-week intervention) groups. Outcomes of both groups will be assessed via clinical scales, sialometry, taste thresholds, and quality-of-life questionnaires at baseline, week 4, and 1, 3-, 6-months and 2 years post (chemo)radiotherapy. The proposed protocol is expected to be feasible in clinical settings, with potential for early detection and prophylactic preservation of taste function in HNC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HNC patients undergoing (chemo)radiotherapy
排除标准
- •cognitive impairments
- •altered states of consciousness
研究组 & 干预措施
Experimental group
4 intervention sessions for dysgeusia and 6 evaluation sessions
干预措施: Prophylactic dysgeusia intervention (Behavioral)
Control group
5 evaluation sessions
结局指标
主要结局
Quantitative taste perception
时间窗: From baseline to 6 months post (chemo)radiotherapy
The primary outcome is the change in quantitative taste perception from baseline to each follow-up evaluation. Taste perception is assessed using a 10-point Likert-scale-based gustatory evaluation, measuring perceived taste modalities (sweet, salty, bitter, and sour). The primary endpoint is defined as the presence or absence of improvement relative to baseline, assessed at Evaluation 2 (end of the intervention, corresponding to week 3 of radiotherapy), Evaluation 3 (1 month after completion of radiotherapy), Evaluation 4 (3 months after completion of radiotherapy), and Evaluation 5 (6 months after completion of radiotherapy).
Quantitative taste perception
时间窗: From baseline to 2 years post (chemo)radiotherapy
The primary outcome is the change in quantitative taste perception from baseline to each follow-up evaluation. Taste perception is assessed using a 10-point Likert-scale-based gustatory evaluation, measuring perceived intensity for solutions of increasing concentrations across four taste modalities (sweet, salty, bitter, and sour). The primary endpoint is defined as the presence or absence of improvement relative to baseline, assessed at Evaluation 2 (end of the intervention, corresponding to week 3 of radiotherapy), Evaluation 3 (1 month after completion of radiotherapy), Evaluation 4 (3 months after completion of radiotherapy), Evaluation 5 (6 months after completion of radiotherapy), and Evaluation 6 (24 months after completion of radiotherapy).
次要结局
- Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale(From baseline to 6 months post (chemo)radiotherapy)
- Sialometry(From baseline to 6 months post (chemo)radiotherapy)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)(From baseline to 6 months post (chemo)radiotherapy)
- Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale(From baseline to 2 years post (chemo)radiotherapy)
- Sialometry(From baseline to 2 years post (chemo)radiotherapy)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)(From baseline to 2 years post (chemo)radiotherapy)