Incidenza Della Disgeusia Nei Pazienti Affetti da Carcinoma Mammario in Trattamento Chemioterapico: Uno Studio Pilota Prospettico
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence of dysgeusia during chemotherapy
研究概览
简要总结
The goal of this observational study is to examine how frequently changes in taste occur in people with early-stage breast cancer who receive chemotherapy. It will also look at how these taste changes affect nutrition and quality of life. The main questions this study aims to answer are:
- How many participants develop changes in taste during chemotherapy?
- How do these changes affect eating habits, nutrition, and daily life?
Participants are women with non-metastatic breast cancer who are receiving chemotherapy before or after surgery.
Researchers will use standardized taste tests to measure how well participants can perceive different flavors. These tests are designed to provide accurate and reproducible results.
Participants will:
- Take part in taste tests during their chemotherapy treatment
- Have their nutritional status evaluated
- Answer questions about their quality of life
详细描述
Dysgeusia, defined as an altered perception of taste, is a frequent but understudied adverse effect of several chemotherapy regimens used for the treatment of breast cancer. Taste alterations may arise from direct cytotoxic effects on taste receptor cells, changes in saliva composition, mucosal inflammation, altered signal transduction, or central nervous system effects. These disturbances can lead to reduced food enjoyment, alterations in dietary patterns, and potential deterioration of nutritional and functional status.
Although dysgeusia is commonly reported in clinical practice, estimates of its prevalence vary widely due to heterogeneous methodologies and the predominant reliance on self-reported symptoms rather than standardized sensory testing. Studies that objectively quantify changes in taste recognition thresholds during chemotherapy are limited, and little is known about specific aspects such as umami perception or chemesthetic sensitivity. Furthermore, factors that may predispose individual patients to developing dysgeusia-such as baseline taster status, nutritional condition, or specific treatment characteristics-remain poorly characterized.
This observational pilot study was designed to provide objective, reproducible data on taste function in patients with non-metastatic breast cancer receiving standard neoadjuvant or adjuvant chemotherapy. A combination of validated sensory tools, including taste strips and chemesthetic tests, is used to measure changes in taste perception over the course of treatment. Standardized methods were selected to ensure high sensitivity and repeatability and to allow quantitative comparison across different time points.
The study also integrates nutritional assessment and quality-of-life evaluation to explore the broader clinical implications of dysgeusia. Particular attention is given to potential associations between objective taste alterations, patient-reported symptoms, and parameters such as nutritional status, dietary intake, and functional well-being. Given the scarcity of comprehensive, methodologically rigorous studies in this area, the data generated may help clarify the clinical burden of dysgeusia and inform strategies to mitigate its impact on patients undergoing chemotherapy for breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Diagnosis of non-metastatic breast cancer
- •Indication for neoadjuvant or adjuvant chemotherapy as part of standard clinical practice
- •Chemotherapy-naïve patients (no chemotherapy received in the previous 12 months)
- •Signed written informed consent
排除标准
- •Terminal or metastatic disease
- •Pre-existing taste or smell disorders (e.g., anosmia, dysgeusia, neurological syndromes, etc.)
- •Known allergies to any substances used in taste and chemesthetic function tests (e.g., quinine dihydrochloride, monosodium L-glutamate, capsaicin, etc.)
- •Receiving neoadjuvant or adjuvant chemotherapy within research protocols
- •Lack of signed written informed consent
结局指标
主要结局
Incidence of dysgeusia during chemotherapy
时间窗: - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after the completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy
The primary endpoint is the incidence of dysgeusia after the start of chemotherapy in participants with non-metastatic breast cancer. Taste perception will be evaluated using standardized taste strips to determine recognition thresholds for four basic tastes (sweet, sour, salty, and bitter). Dysgeusia will be considered present if the total taste strip score is lower than 9 at any of the evaluated time points.
次要结局
- Quantitative changes in taste recognition thresholds(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Chemesthetic sensitivity assessed by capsaicin strips(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Taster status assessment(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Chemotherapy-induced taste alteration (CiTAS) questionnaire(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Nutritional status assessment(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Caloric and macronutrient intake(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)
- Quality of life assessment (FACT-G)(- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy)