Endometrium CancerNCT03095664
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
A study testing Intervention group in people with Endometrium Cancer and Life Style, run by Brazilian National Cancer Institute at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women only
- Conditions the study is for
- Endometrium Cancer, Life Style, Obesity
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endometrial cancer patients undergoing surgical treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brazilian National Cancer Institute
Rio de Janeiro, Rio de Janeiro, 20220-410
About this study
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.
Read the 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.
- Conditions
- Endometrium Cancer, Life Style, Obesity
- Being tested
- Intervention group
- Keywords
- lifestyle intervention, endometrial cancer, survival
- Medical subject headings
- Endometrial Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Also called Lifestyle intervention counseling program
A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity. Receives: Behavioral: Intervention group |
| Control group | No intervention | Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
mortality after 5 years
Measured: 5 years
Secondary outcomes (13)
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.
Measured: 0, 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.
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 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
Measured: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Disease-free survival
Disease-free survival after 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study startNov 2016
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrium CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brazilian National Cancer Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gabriela Villaça Chaves, Brazilian National Cancer Institute
- Investigators
- Gabriela V Chaves, PhD, Principal investigator, Brazilian National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095664
- Sponsor's protocol ID
- 55155116.9.0000.5274
- Status last verified
- Jun 2021
- First submitted
- 14 Mar 2017
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.
PubMed 36971688
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT03095664
- Acronym / sponsor ID
- 55155116.9.0000.5274
- Conditions
- Endometrium Cancer, Life Style, Obesity
- Keywords
- lifestyle intervention, endometrial cancer, survival
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Brazilian National Cancer InstituteOther government
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention group6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity. |
| Control group | No intervention | –Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge). |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- endometrial cancer patients undergoing surgical treatment
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupAlso: Lifestyle intervention counseling programA behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity. | Behavioural | Intervention group |
Primary outcome
Overall survival
Time frame: 5 years
mortality after 5 years
13 secondary outcomes
Change in Quality of life
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in handgrip strength
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
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 (Timed Get Up and Go test)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in functional capacity (6 minute walk test)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in Physical activity behaviour
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in food intake pattern
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in Body composition
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (weight)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (body mass index)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (waist circumference)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Change in anthropometric status (hip circumference)
Time frame: 0, 6, 12, 24, 26, 48 and 60 months after surgery
Disease-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 36971688Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela V Chaves, PhD principal investigator
Brazilian National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Endometrium Cancer and Life Style, run by Brazilian National Cancer Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.