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临床试验/NCT03095664
NCT03095664暂停不适用

Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

Brazilian National Cancer Institute2 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
286
试验地点
2
主要终点
Overall survival

研究概览

简要总结

The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.

详细描述

Endometrial cancer (EC) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. The incidence of EC is higher in high-income countries, but it has been increasing in low- and middle-income countries.

The main risk factors for EC include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. Obesity is recognized as a major risk factor for many cancers, including EC. Multiple mechanisms related to obesity are probably involved in the carcinogenesis of EC. Among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. These estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (SHBG) in the liver. Insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of EC.

Although the incidence of EC is remarkable, insufficient data has addressed the impact of obesity on EC outcomes. Since about 70% of women diagnosed with endometriod EC are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women.

Sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. However, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. Studies assessing nutritional status and lifestyle before and after EC diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • endometrial cancer patients undergoing surgical treatment

排除标准

  • previous oncologic treatment
  • cancer stage IV according to the International Federation of Gynecology and Obstetrics (FIGO)
  • patients who report physical activity over 150 minutes/week of moderate or vigorous intensity
  • individuals with decompensated diabetes mellitus or hypertension
  • patients who have a contraindication to physical activity.

结局指标

主要结局

Overall survival

时间窗: 5 years

mortality after 5 years

次要结局

  • Change in Physical activity behaviour(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Disease-free survival(5 years)
  • Change in functional capacity (6 minute walk test)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in food intake pattern(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in Quality of life(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in functional capacity (Timed Get Up and Go test)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in anthropometric status (hip circumference)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in handgrip strength(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in functional capacity (30 second stand chair test)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in anthropometric status (weight)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in anthropometric status (waist circumference)(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in Body composition(0, 6, 12, 24, 26, 48 and 60 months after surgery)
  • Change in anthropometric status (body mass index)(0, 6, 12, 24, 26, 48 and 60 months after surgery)

研究者

发起方
Brazilian National Cancer Institute
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gabriela Villaça Chaves

PhD, researcher

Brazilian National Cancer Institute

研究点 (2)

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