Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
Primary Purpose
Endometrium Cancer, Life Style, Obesity
Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Endometrium Cancer focused on measuring lifestyle intervention, endometrial cancer, 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.
Sites / Locations
- Brazilian National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.
Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).
Outcomes
Primary Outcome Measures
Overall survival
mortality after 5 years
Secondary Outcome Measures
Change in Quality of life
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.
Change in handgrip strength
Change in handgrip strength before and 6, 12, 24, 26, 48 and 60 months after surgery.
Change in functional capacity (30 second stand chair test)
change in functional capacity assessed by 30 second stand chair test before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (Timed Get Up and Go test)
change in functional capacity assessed by Timed Get Up and Go test before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (6 minute walk test)
change in functional capacity assessed by 6 minute walk test before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in Physical activity behaviour
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
Change in food intake pattern
change in food intake pattern assessed by Food Frequency questionaire before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in Body composition
change in body composition assessed by bioelectrical impedance before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (weight)
change in weight before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (body mass index)
change in body mass index before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (waist circumference)
change in waist circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (hip circumference)
change in hip circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
Disease-free survival
Disease-free survival after 5 years
Full Information
NCT ID
NCT03095664
First Posted
March 14, 2017
Last Updated
June 29, 2021
Sponsor
Brazilian National Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03095664
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Suspended
Why Stopped
Study stopped due to COVID-19 pandemic, as conducting a behaviour-change programme in groups was not recommended to prevent the spread of the virus.
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brazilian National Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrium Cancer, Life Style, Obesity
Keywords
lifestyle intervention, endometrial cancer, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Lifestyle intervention counseling program
Intervention Description
A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.
Primary Outcome Measure Information:
Title
Overall survival
Description
mortality after 5 years
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
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.
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in handgrip strength
Description
Change in handgrip strength before and 6, 12, 24, 26, 48 and 60 months after surgery.
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in functional capacity (30 second stand chair test)
Description
change in functional capacity assessed by 30 second stand chair test before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in functional capacity (Timed Get Up and Go test)
Description
change in functional capacity assessed by Timed Get Up and Go test before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in functional capacity (6 minute walk test)
Description
change in functional capacity assessed by 6 minute walk test before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in Physical activity behaviour
Description
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
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in food intake pattern
Description
change in food intake pattern assessed by Food Frequency questionaire before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in Body composition
Description
change in body composition assessed by bioelectrical impedance before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in anthropometric status (weight)
Description
change in weight before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in anthropometric status (body mass index)
Description
change in body mass index before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in anthropometric status (waist circumference)
Description
change in waist circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Change in anthropometric status (hip circumference)
Description
change in hip circumference before and 6, 12, 24, 26, 48 and 60 months after surgery
Time Frame
0, 6, 12, 24, 26, 48 and 60 months after surgery
Title
Disease-free survival
Description
Disease-free survival after 5 years
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela V Chaves, PhD
Organizational Affiliation
Brazilian National Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazilian National Cancer Institute
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20220-410
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
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