Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endometrium Cancer
- Sponsor
- Brazilian National Cancer Institute
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Suspended
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Gabriela Villaça Chaves
PhD, researcher
Brazilian National Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •endometrial cancer patients undergoing surgical treatment
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 5 years
mortality after 5 years
Secondary Outcomes
- 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)