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

B

Brazilian National Cancer Institute

Status

Suspended

Conditions

Endometrium Cancer
Life Style
Obesity

Treatments

Behavioral: Intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT03095664
55155116.9.0000.5274

Details and patient eligibility

About

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.

Full 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.

Enrollment

286 estimated patients

Sex

Female

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

286 participants in 2 patient groups

Intervention group
Experimental group
Description:
6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.
Treatment:
Behavioral: Intervention group
Control group
No Intervention group
Description:
Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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