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

June 29, 2021 updated by: Gabriela Villaça Chaves, Brazilian National Cancer Institute
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20220-410
        • Brazilian National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.
Behavioral: Intervention group
A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.
Other Names:
  • Lifestyle intervention counseling program
No Intervention: Control group
Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
mortality after 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in quality of life assessed by the Quality of Life-30 (QL30) questionaire of the European Organisation for Research and Treatment of Cancer (EORCT) before and 6, 12, 24, 26, 48 and 60 months after surgery.
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in handgrip strength
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in handgrip strength before and 6, 12, 24, 26, 48 and 60 months after surgery.
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (30 second stand chair test)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in functional capacity assessed by 30 second stand chair test before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (Timed Get Up and Go test)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in functional capacity assessed by Timed Get Up and Go test before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (6 minute walk test)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in functional capacity assessed by 6 minute walk test before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in Physical activity behaviour
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in physical activity behaviour assessed by The International Physical Activity Questionnaire (IPAQ) before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in food intake pattern
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in food intake pattern assessed by Food Frequency questionaire before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in Body composition
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in body composition assessed by bioelectrical impedance before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (weight)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in weight before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (body mass index)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in body mass index before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (waist circumference)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in waist circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (hip circumference)
Time Frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
change in hip circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
0, 6, 12, 24, 26, 48 and 60 months after surgery
Disease-free survival
Time Frame: 5 years
Disease-free survival after 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilian National Cancer Institute

Investigators

  • Principal Investigator: Gabriela V Chaves, PhD, Brazilian National Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55155116.9.0000.5274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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