Obesity Clinical Trial
Official title:
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
Verified date | June 2021 |
Source | Brazilian National Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 286 |
Est. completion date | November 2025 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 69 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Brazilian National Cancer Institute | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Brazilian National Cancer Institute |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | mortality after 5 years | 5 years | |
Secondary | 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. | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | Change in handgrip strength | 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 | |
Secondary | 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 | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | 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 | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | 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 | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | 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 | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | 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 | 0, 6, 12, 24, 26, 48 and 60 months after surgery | |
Secondary | Change in Body composition | 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 | |
Secondary | Change in anthropometric status (weight) | 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 | |
Secondary | Change in anthropometric status (body mass index) | 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 | |
Secondary | Change in anthropometric status (waist circumference) | 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 | |
Secondary | Change in anthropometric status (hip circumference) | 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 | |
Secondary | Disease-free survival | Disease-free survival after 5 years | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |