Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
研究概览
简要总结
In post-menopause women affected by breast cancer and treated with chemotherapy, overweight and obesity are considered both a risk factors as well as a negative prognostic factors since they increase the risk of early relapse and death. Furthermore, a decrease in weight may also occur during chemotherapy and is associated to a reduced quality of life and survival. Also, the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast cancer and under chemotherapy treatment and to better understand how this alterations influence the quality of life, anxiety, depression and insomnia of patients as well as overall survival.
详细描述
INTRODUCTION
Overweight and obesity represent a risk factor for hormone dependent cancers such as breast, endometrium, ovarian, uterine and gastrointestinal cancer.
In particular, overweight and obesity are risk factors for breast cancer in post-menopause women since they are associated to higher level of circulating estrogens, insulin, insulin-like growth factor levels, leptin, adiponectin, growth factors (such as hepatocyte growth factor) and inflammatory cytokines (TNFα and Interleukin-6 (IL-6)). Moreover, they reduce sex hormone binding globulin (SHBG) plasma levels. Overweight and obesity are also negative prognostic factors for breast cancer in post-menopause women since they increase the risk of early relapse and death. An increased weight (2.5-6.2 Kg) is commonly reported during chemotherapy treatment in post-menopause women. This is due to increased appetite, hyperphagia and hydric retention associated with reduced metabolism and physic activities. However, the weight gain during therapy is still not recognised as a negative prognostic factor.
Furthermore, a decrease in weight may also occur during chemotherapy. This is mainly due to lower appetite and early satiety, dysgeusia, nausea and vomiting or intolerance to certain foods. Decreasing weight can determine less efficacy and tolerance in therapy, more complications/infections, more and longer hospitalisations and, as a consequence, a reduced quality of life and survival.
Dysgeusia is an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. More than 75% of patients under chemotherapy refer dysgeusia; this is related to drugs (such as folic acid competitors, cyclophosphamide cisplatin and taxanes) and can last for weeks. ln particular, taxanes determine a peripheral nerves degeneration. The results are a metallic taste and an alteration in salted perception. In addition, they determine a dose-dependent chemotherapy-induced peripheral neuropathy (CIPN) with painful paraesthesia, total areflexia and muscular extremities weakness. Dysgeusia is an underestimated problem. Instrumental examinations and laboratory tests can be useful but they cannot replace a detailed medical history and a close physical examination associated with international validate questionnaires.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre- and post-menopause women with histologic diagnosis of invasive breast cancer surgically treated (all pT and all pN)
- •Patients must provide written informed consent to be enrolled in the study
排除标准
- •Locally extended or metastatic (M1) disease;
- •Previous surgical or radio therapeutic treatment (up to one year before the selection) in oral or nasal region;
- •Other serious medical conditions that can limit patient capability to participate in this study.
结局指标
主要结局
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
时间窗: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Appearence of dysgeusia, asthenia, diarrhoea, decreased or increased appetite, mucositis, nausea, stypsis, vomiting and meteorism will be evaluated throught Food frequency questionaire (FFQ) compared to baseline (nefore chemotherapy)
次要结局
- Evaluation of dysgeusia(From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of eating habits changes(from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of the impact of eating habits changes and dysgeusia on quality of life(from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of weight alterations(From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of the impact of eating habits changes and dysgeusia on depression(from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of the impact of eating habits changes and dysgeusia on insomnia(from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
- Evaluation of the impact of eating habits changes and dysgeusia on anxiety, depression(from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy)
研究者
LUCIA VASSALLI
MD
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
