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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03095664
• Other study ID #: 55155116.9.0000.5274
• Status: Suspended
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2025

Study information

• Verified date: June 2021
• Source: Brazilian National Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer
• Life Style
• Obesity

Intervention

Behavioral:
• Intervention group
A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.

Locations

Country	Name	City	State
Brazil	Brazilian National Cancer Institute	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Brazilian National Cancer Institute

Country where clinical trial is conducted

Brazil, 

Outcome

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