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

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ClinicalTrials.gov Identifier: NCT03095664
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriela Villaça Chaves, Brazilian National Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Endometrium Cancer Life Style Obesity Behavioral: Intervention group Not Applicable

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.


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Study Type : Interventional
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
Study Start Date : November 2016
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


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 Name: Lifestyle intervention counseling program

No Intervention: Control group
Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    mortality after 5 years


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Disease-free survival [ Time Frame: 5 years ]
    Disease-free survival after 5 years



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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095664


Contacts
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Contact: Gabriela V Chaves, PhD +552132072846 gabrielavc@gmail.com

Locations
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Brazil
Brazilian National Cancer Institute Recruiting
Rio de Janeiro, RJ, Brazil, 20220-410
Contact: Gabriela V Chaves, PhD    5521 32072846    gabrielavc@gmail.com   
Sponsors and Collaborators
Brazilian National Cancer Institute
Investigators
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Principal Investigator: Gabriela V Chaves, PhD Brazilian National Cancer Institute

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Responsible Party: Gabriela Villaça Chaves, PhD, researcher, Brazilian National Cancer Institute
ClinicalTrials.gov Identifier: NCT03095664     History of Changes
Other Study ID Numbers: 55155116.9.0000.5274
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gabriela Villaça Chaves, Brazilian National Cancer Institute:
lifestyle intervention
endometrial cancer
survival

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female