Clinical trial NCT03095664: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Endometrium Cancer
Life Style
Obesity
Keywords: lifestyle intervention
endometrial cancer
survival
Lead sponsor: Brazilian National Cancer Institute
Sponsor class: OTHER_GOV
First posted: 2017-03-30
Enrollment: 286
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in handgrip strength
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in functional capacity (30 second stand chair test)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in functional capacity (Timed Get Up and Go test)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in functional capacity (6 minute walk test)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in Physical activity behaviour
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in food intake pattern
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in Body composition
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in anthropometric status (weight)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in anthropometric status (body mass index)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in anthropometric status (waist circumference)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Change in anthropometric status (hip circumference)
timeFrame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
measure: Disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Brazilian National Cancer Institute
state: RJ
Study officials:
affiliation: Brazilian National Cancer Institute
name: Gabriela V Chaves, PhD
role: PRINCIPAL_INVESTIGATOR
References: