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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

NCT00262938

Endometrial Cancer Weight Changes

COMPLETED NA

Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer

NCT06312917

Endometrium Cancer Physical Activity Weight Management

COMPLETED NA

Translating Healthy Lifestyle Interventions for Cancer Survivors

NCT02690766

Diabetes Mellitus, Non-Insulin-Dependent Breast Cancer Endometrial Cancer

COMPLETED NA

Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

NCT02575872

Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Stage II Uterine Corpus Cancer +5 more

COMPLETED NA

Diet and Physical Activity in Uterine Cancer Survivors

NCT02433080

Endometrial Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrium Cancer Life Style Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.

Group Type EXPERIMENTAL

Intervention group

Intervention Type BEHAVIORAL

A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.

Control group

Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention group

A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lifestyle intervention counseling program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No