Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dysgeusia (BITTER Perception)
研究概览
简要总结
One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.
详细描述
Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people.
Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease and in the National Cancer Institute of Mexico exclusively less than 2%, representing chemotherapy the standard of care in these patients.
One of the most widely used drug combinations is paclitaxel-cisplatin. It has been reported a prevalence of malnutrition in 60 to 79% in this type of cancer, being the major contributor to morbidity and mortality. The etiology resides both in the systemic effects of the tumor and toxic effects of treatment as low levels hematologic, nausea, vomiting, mucositis, anorexia, dysgeusia, among others.
Weight loss has a strong impact on the response to chemotherapy, radiotherapy and surgery, as well as increased toxic effects impacting the discontinuation of treatment and is considered an independent predictor of survival for most patients with NSCLC. Is estimated that over 20% of cancer patients the cause of death are inanition effects.
Among the most frequent symptoms in advanced unresectable cancer or its treatment that may affect food intake and hence nutritional status, are the early satiety and dysgeusia (61% and 46% respectively). As are difficult to change early satiety, dysgeusia is a field for selecting strategies in its management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV
- •ECOG score ≤ 2
- •Candidates for first-line chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks
- •Signed informed consent (and ethical scientific committee No. (010/023 (IMO) (CB/618
排除标准
- •Patients who withdraw their consent and not want to continue with the evaluation of the study
- •Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa
- •People diagnosed with epilepsy or some other neurological disorders associated
- •Concomitant radiotherapy in head and neck.
结局指标
主要结局
Dysgeusia (BITTER Perception)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
Dysgeusia (UMAMI Perception)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
Dysgeusia (UMAMI Recognition)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
Dysgeusia (SWEET Perception)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
Dysgeusia (UMAMI Dilutions Dichotomized)
时间窗: pre - post chemotherapy (6 weeks)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)
Dysgeusia (BITTER Dilutions Dichotomized)
时间窗: pre - post chemotherapy (6 weeks)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes
Dysgeusia (SWEET Recognition)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
Dysgeusia (SWEET Dilutions Dichotomized)
时间窗: pre - post chemotherapy (6 weeks)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.
Dysgeusia (BITTER Recognition)
时间窗: Change from Baseline in threshold of perception at 6 weeks
Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.
次要结局
- Change From Baseline in Albumin After 2 Cycles of Chemotherapy(participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks)
- BODY COMPOSITION(Change from Baseline in perception and recognition thresholds at 6 weeks)
- Body Mass Index(Change from Baseline in threshold of perception and recognition at 6 weeks)
- Global Status of Quality of Life (C-30,LC13 EORTC)(time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks)
- Subjective Global Assessment(descriptive values before chemotherapy)
- PROTEIN AND FAT Consumption(participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks)
- Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)(participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks)
- IRON Consumption(participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks)
- Quality o f Life(participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks)
研究者
Oscar Gerardo Arrieta Rodríguez
Head Of the Thoracic Oncology Clinic. SNI II
Instituto Nacional de Cancerologia de Mexico