Endometrial CancerNCT00732173
Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer
A study testing behavioral dietary intervention, exercise intervention and counseling intervention in people with Endometrial Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer. PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- behavioral dietary intervention, exercise intervention and counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I or II (early) endometrial carcinoma
- Diagnosed within the past 3 years
- Underwent prior surgery consisting of a total abdominal hysterectomy and bilateral salpingo-oophorectomy
- No evidence of disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- BMI ≥ 25 (overweight/obese)
- Medical clearance from primary care physician
- Approved for contact by treating gynecologic oncologist
- At least a 6th-grade reading level to complete significant reading and homework
- No severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or major depression (Beck Depression Inventory > 29) that needs more aggressive, problem-focused interventions
- No dementia or cognitive deficits
- No pre-existing medical conditions that would be a barrier for participation in unsupervised walking
- No participation in a structured weight loss or exercise program in the past 6 months
- Must agree to and be available for longitudinal follow-up assessments
- Non-English speakers may bring an English-speaking person to all group sessions and visits
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)
RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer.
PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To reduce morbidity and early mortality in endometrial cancer (EC) survivors through obesity management.
SECONDARY OBJECTIVES:
- To expand and refine a previous pilot study of a behavioral, lifestyle-change education intervention for use in overweight and obese patients in remission from endometrial carcinoma.
- To determine the potential effects and variation of each regimen in these patients.
- To explore potential mediators (self-efficacy, depression) and moderators (body mass index) of healthful dietary and exercise behaviors.
- To evaluate neuronal response to high-versus-low calorie visual food stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (hypothalamus, lateral orbitofrontal cortex, ventral striatum, insula) using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) before and after a lifestyle (diet and exercise counseling) intervention or usual care in obese EC patients. We will also compare the neuronal responses in obese EC patients to those from normal weight subjects without cancer being seen at the same gynecologic clinic; and, explore modification of the neuronal signals by candidate genes and serum biomarkers in the hypothalamic pituitary-adrenal axis, serotonergic and inflammatory pathways.
OUTLINE: Patients are stratified according to body mass index (25.0-39.9 vs ≥ 40) and randomized to 1 of 2 intervention arms.
- Arm I: Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
- Arm II (control): Patients receive usual care informational brochures, but no lifestyle counseling, related to weight loss, physical activity, and nutrition.
Patients undergo physician counseling sessions at baseline and 3, 6, and 12 months. Patients are assessed by weight, anthropometric measures, and body mass index; biomarkers; body composition by dual-energy x-ray absorptiometry/densitometry (DEXA); co-morbidities by the Charlson co-morbidity score; depression by the Beck Depression Inventory (BDI); eating patterns by the Three-Factor Eating Inventory (EI); exercise/physical activity by Leisure Score Index (LSI) and pedometer step count; nutrient intake by 24-hour recall; quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) and Short-form Medical Outcomes (SF-36); and self-efficacy by the Self-Efficacy Questionnaire (SEQ) and the Weight Efficacy Life-Style (WEL).
- Conditions
- Endometrial Cancer
- Being tested
- behavioral dietary intervention, exercise intervention, counseling intervention, educational intervention, survey administration
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
Undergo SUCCEED lifestyle intervention
exercise interventionBehavioural
Undergo SUCCEED lifestyle intervention
counseling interventionOther
Undergo SUCCEED lifestyle intervention
educational interventionOther
Receive information
survey administrationOther
Undergo SUCCEED lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact. Receives: Behavioral: behavioral dietary intervention; Behavioral: exercise intervention; Other: counseling intervention; Other: educational intervention; Other: survey administration |
| Arm II | Active comparator | Patients receive usual care informational brochures but no lifestyle counseling related to weight loss, physical activity, and nutrition. Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero.
Measured: at baseline and 3, 6, and 12 months.
Secondary outcomes (7)
Quantitative and qualitative nutrient intake
24 hour dietary recalls will be conducted using the United States Department of Agriculture (USDA) 5 Step Multiple Pass Method. Information about dietary supplement use will also be obtained. Food intake will be entered into Nutritionist Pro. Fruit/vegetable intake will be assessed using the National Cancer Institute (NCI) All-Day Fruit and Vegetable Screener, which has 10 questions which assess intake of fruits and vegetables during the previous month. A mixed modeling approach will be used.
Measured: at baseline and 3, 6, and 12 months.
Minutes spent in moderate and vigorous physical activity
Assessed with the validated Godin Leisure-Time Exercise questionnaire, a four-item query of usual leisure-time exercise habits. Average frequency of milk, moderate, and strenuous exercise during a typical week are assessed. Duration in minutes of activity along with specific questions regarding walking are included. Complete 7-day pedometer step test at baseline and at 6 and 12 months. A mixed modeling approach will be used.
Measured: at baseline and 3, 6, and 12 months.
Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology
Measured in a random subsample. Lean body mass, body fat composition, and bone mineral density will be measured. Body composition will be analyzed to determine changes along with weight to help track effectiveness of the intervention.
Measured: at baseline and 3, 6, and 12 months.
Biomarkers for metabolic syndrome and nutrition
Serum biomarkers analyzed for changes along with weight to help track effectiveness of the intervention. Risk factors of metabolic syndrome: low density lipoprotein (LDL), high density lipoprotein (HDL), serum triglycerides, and fasting glucose. Plasma carotenoids (alpha-carotene, beta-carotene, lutein, zeaxanthin) and lycopene concentrations for changes in fruit and vegetable intake. Sub-Study, serum for appetite-related hormones and inflammatory cytokines: leptin, insulin, adiponectin, resistin, IGF-1, IGFBP-1, IGFBP-3, IL-6, TNF-α, MCP-1, glucagon, GLP-1 active, and thyroid hormones.
Measured: at baseline and 3, 6, and 12 months.
Self-efficacy
Self-Efficacy Questionnaire: Physical Activities, an 8 item measure of respondents' perception of the degree to which they feel able to make changes in their physical activity level. Weight Efficacy Life-Style (WEL) questionnaire, 20 questions in 5 situational factors, where subjects rate their ability to successfully resist the desire to eat using a 10-point scale. Methodology of Baron and Kenny used to test for mediating effect of self-efficacy. Multiple regression analyses used to provide statistical tests of the possible mediating role of self-efficacy.
Measured: at baseline and 3, 6, and 12 months.
Depression
Assessed using the Beck Depression Inventory (BDI), a 21-item, Likert-scaled instrument of depressive symptoms. Methodology of Baron and Kenny used to test for mediating effect of depression. Multiple regression analyses used to provide statistical tests of the possible mediating role of depression.
Measured: at baseline and 3, 6, and 12 months.
Quality of life
Using Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating various domains of QOL including physical, functional, family-social, and emotional well-being with questions answered on a 5-point Likert scale and items summated to give scores for each domain; a 13-item fatigue subscale; and the FACT-Endometrial (En), a 16-item subscale specific for EC. Also using Short-Form (SF)-36, with 36 questions scored on a Likert scale, producing overall physical and mental component summary measures. Baseline scores entered in the regression models.
Measured: at baseline and 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2011
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 Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter G. Rose, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterVivian von Gruenigen, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732173
- Sponsor's protocol ID
- CASE8808
- Other IDs
- P30CA043703, CASE8808, CASE-8808-CC516
- Status last verified
- Feb 2013
- First submitted
- 8 Aug 2008
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3.
PubMed 21173649
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)
- ClinicalTrials.gov ID
- NCT00732173
- Acronym / sponsor ID
- CASE8808
- Conditions
- Endometrial Cancer
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Aug 2008 (estimated)
- 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.
RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer.
PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer.
Detailed description
PRIMARY OBJECTIVE:
- To reduce morbidity and early mortality in endometrial cancer (EC) survivors through obesity management.
SECONDARY OBJECTIVES:
- To expand and refine a previous pilot study of a behavioral, lifestyle-change education intervention for use in overweight and obese patients in remission from endometrial carcinoma.
- To determine the potential effects and variation of each regimen in these patients.
- To explore potential mediators (self-efficacy, depression) and moderators (body mass index) of healthful dietary and exercise behaviors.
- To evaluate neuronal response to high-versus-low calorie visual food stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (hypothalamus, lateral orbitofrontal cortex, ventral striatum, insula) using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) before and after a lifestyle (diet and exercise counseling) intervention or usual care in obese EC patients. We will also compare the neuronal responses in obese EC patients to those from normal weight subjects without cancer being seen at the same gynecologic clinic; and, explore modification of the neuronal signals by candidate genes and serum biomarkers in the hypothalamic pituitary-adrenal axis, serotonergic and inflammatory pathways.
OUTLINE: Patients are stratified according to body mass index (25.0-39.9 vs ≥ 40) and randomized to 1 of 2 intervention arms.
- Arm I: Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
- Arm II (control): Patients receive usual care informational brochures, but no lifestyle counseling, related to weight loss, physical activity, and nutrition.
Patients undergo physician counseling sessions at baseline and 3, 6, and 12 months. Patients are assessed by weight, anthropometric measures, and body mass index; biomarkers; body composition by dual-energy x-ray absorptiometry/densitometry (DEXA); co-morbidities by the Charlson co-morbidity score; depression by the Beck Depression Inventory (BDI); eating patterns by the Three-Factor Eating Inventory (EI); exercise/physical activity by Leisure Score Index (LSI) and pedometer step count; nutrient intake by 24-hour recall; quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) and Short-form Medical Outcomes (SF-36); and self-efficacy by the Self-Efficacy Questionnaire (SEQ) and the Weight Efficacy Life-Style (WEL).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Behavioral: behavioral dietary intervention, Behavioral: exercise intervention, Other: counseling intervention, Other: educational intervention, Other: survey administrationPatients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact. |
| Arm II | Active comparator | Other: educational interventionPatients receive usual care informational brochures but no lifestyle counseling related to weight loss, physical activity, and nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| behavioral dietary interventionUndergo SUCCEED lifestyle intervention | Behavioural | Arm I |
| exercise interventionUndergo SUCCEED lifestyle intervention | Behavioural | Arm I |
| counseling interventionUndergo SUCCEED lifestyle intervention | Other | Arm I |
| educational interventionReceive information | Other | Arm I, Arm II |
| survey administrationUndergo SUCCEED lifestyle intervention | Other | Arm I |
Primary outcome
Weight change
Time frame: at baseline and 3, 6, and 12 months.
Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero.
7 secondary outcomes
Quantitative and qualitative nutrient intake
Time frame: at baseline and 3, 6, and 12 months.
Minutes spent in moderate and vigorous physical activity
Time frame: at baseline and 3, 6, and 12 months.
Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology
Time frame: at baseline and 3, 6, and 12 months.
Biomarkers for metabolic syndrome and nutrition
Time frame: at baseline and 3, 6, and 12 months.
Self-efficacy
Time frame: at baseline and 3, 6, and 12 months.
Depression
Time frame: at baseline and 3, 6, and 12 months.
Quality of life
Time frame: at baseline and 3, 6, and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Derived from this study: PubMed 21173649von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3.
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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.
Peter G. Rose, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Vivian von Gruenigen, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, exercise intervention and counseling intervention in people with Endometrial Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Feb 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight change (time frame: at baseline and 3, 6, and 12 months.). 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 NCT00732173, 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 8 Feb 2013.