Early Stage Endometrial CancerNCT02987881
Endometrial Cancer Diet and Exercise
A study testing Home-based aerobic exercise and nutritional counseling in people with Early Stage Endometrial Cancer, run by Duke University at 1 site in United States.
Trial summary
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Endometrial Cancer
- What is being tested?
- Home-based aerobic exercise and nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Jun 2019
- 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
Who may be able to join
- Ages > 18 years.
- Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.
- At least 2 months was passed since the hysterectomy and enrollment.
- Karnofsky performance status > 70%.
- Body mass index of 30.0 - 49.9 and body weight < 300 pounds.
- No plan for adjuvant endometrial cancer therapy.
Show all 22Show fewer
- Able to exercise safely on a treadmill.
- No absolute contraindications to exercise testing as recommended by the American Thoracic Society. No recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
- The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
- Able to provide informed consent.
- Have reliable transportation to the testing facilities.
- Subjects must be able to speak and understand English to participate in this study.
- Subjects must have a personal mobile device compatible for the activity monitor
- Compatible devices for the activity monitors are below:
- Android
- o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later.
- iOS
- iPhone 4s (or newer)
- iPod touch (5th generation or newer)
- iPad (3rd generation or newer)
- iPad mini (1st generation or newer)
- iPad Air (1st generation or newer)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.
- Conditions
- Early Stage Endometrial Cancer
- Being tested
- Home-based aerobic exercise and nutritional counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based aerobic exercise and nutritional counselingBehavioural
Moderate walking and running with nutritional counseling at study visits.
| Study group | Role | What they receive |
|---|---|---|
| Adult women with early stage localized endometrial cancer | Experimental | Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy Receives: Behavioral: Home-based aerobic exercise and nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by adherence to weekly walking sessions
Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
Measured: Week 12
Safety as measured by the type and prevalence of adverse events during study-related assessments
Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
Measured: Week 12
change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
Measured: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
Measured: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
Measured: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
Measured: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by body composition
Measured: baseline and 12 weeks
Secondary outcomes (1)
patient experience with exercise and nutrition counseling as measured by telephone questionnaire
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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 Early Stage Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Angeles A Secord, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987881
- Sponsor's protocol ID
- Pro00074542
- Status last verified
- Jun 2019
- First submitted
- 6 Dec 2016
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.
PubMed 34178654
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT02987881
- Acronym / sponsor ID
- Pro00074542
- Conditions
- Early Stage Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Cancer Institute
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Dec 2016 (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.
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult women with early stage localized endometrial cancer | Experimental | Behavioral: Home-based aerobic exercise and nutritional counselingAdult women with early stage localized endometrial cancer at least 2 months following hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Ages > 18 years.
- Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.
- At least 2 months was passed since the hysterectomy and enrollment.
- Karnofsky performance status > 70%.
- Body mass index of 30.0 - 49.9 and body weight < 300 pounds.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Home-based aerobic exercise and nutritional counselingModerate walking and running with nutritional counseling at study visits. | Behavioural | Adult women with early stage localized endometrial cancer |
Primary outcome
Feasibility as measured by adherence to weekly walking sessions
Time frame: Week 12
Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
Safety as measured by the type and prevalence of adverse events during study-related assessments
Time frame: Week 12
Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
Time frame: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
Time frame: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
Time frame: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
Time frame: baseline and 12 weeks
change in cardiorespiratory fitness and CVD risk profile as measured by body composition
Time frame: baseline and 12 weeks
1 secondary outcome
patient experience with exercise and nutrition counseling as measured by telephone questionnaire
Time frame: 16 weeks
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 2 Aug 2021.
- Results publication: PubMed 34178654Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Angeles A Secord, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based aerobic exercise and nutritional counseling in people with Early Stage Endometrial Cancer, run by Duke University 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?
The sponsor lists 22 inclusion and 1 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: finished, as of the sponsor's last update on 2 Aug 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 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?
Feasibility as measured by adherence to weekly walking sessions (time frame: Week 12). The study lists 7 primary outcomes in all. 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 NCT02987881, 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 2 Aug 2021.