Brief Title
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
Official Title
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
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.
Study Type
Interventional
Primary Outcome
Overall survival
Secondary Outcome
Change in Quality of life
Condition
Endometrium Cancer
Intervention
Intervention group
Study Arms / Comparison Groups
Intervention group
Description: 6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
286
Start Date
November 2016
Completion Date
November 2025
Primary Completion Date
November 2023
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.
Gender
Female
Ages
20 Years - 69 Years
Accepts Healthy Volunteers
No
Contacts
Gabriela V Chaves, PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT03095664
Organization ID
55155116.9.0000.5274
Responsible Party
Principal Investigator
Study Sponsor
Brazilian National Cancer Institute
Study Sponsor
Gabriela V Chaves, PhD, Principal Investigator, Brazilian National Cancer Institute
Verification Date
June 2021