Endometrial CancerNCT04025229
High Intensity Interval Training in Endometrial Cancer
A study testing HIIT exercise in people with Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- HIIT exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 8 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging
- Between 40-75 years old
- Body mass index of 30-50 kg/m2
- Endometrioid histology endometrial cancer
- Presumed clinically early stage disease (disease confined to uterus only)
- Have access to a Smart Phone
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- Have access to email
- Agree to visit the exercise and sport science laboratory within 2 days of SOC visit for baseline testing if enrollment procedures cannot be done on the same day.
- Agree to visit clinic 2 (+/-2wks) weeks after surgery for SOC follow-up and post surgery visit, or willing to return to exercise and sport science laboratory 2 (+/-2wks) weeks post-surgery
Who cannot join
- Meets American College of Sports Medicine Guidelines for physical activity (150 minutes / week)
- Currently doing HIIT
- Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
- Active diagnosis of psychosis or current uncontrolled substance abuse disorder
- Insulin-dependent diabetes
- Currently in another EC intervention
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- Severe dementia or other memory loss condition
- Severe mental health disorder
- Severely impaired hearing or speech
- Inability to speak English
- Musculoskeletal or neuromuscular condition that limits physical activity Any condition, in the opinion of the investigators, which would prohibit safe participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer
This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P
Read the detailed description
Primary Objectives:
- Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer 2. Participants will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. Blood will be collected twice during standard of care blood draws.
- Conditions
- Endometrial Cancer
- Being tested
- HIIT exercise
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT exerciseBehavioural
High intensity interval training (4 to 6 sessions) prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| HIIT exercise | Experimental | Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery Receives: Behavioral: HIIT exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proliferative Markers in Endometrium Before and After HIIT Exercises
Change in Ki-67 proliferation values within the HIIT intervention group between the initial biopsy and the surgical biopsy. The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start23 Sep 2019
- Primary completion8 Sep 2024
- Study completion8 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will complete HIIT training prior to surgery
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Victoria Bae-Jump, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025229
- Sponsor's protocol ID
- LCCC 1839
- Other IDs
- 1R21CA235029-01
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2019
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04025229
- Acronym / sponsor ID
- LCCC 1839
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P
Detailed description
Primary Objectives:
- Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer 2. Participants will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. Blood will be collected twice during standard of care blood draws.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will complete HIIT training prior to surgery
| Arm | Type | Receives |
|---|---|---|
| HIIT exercise | Experimental | Behavioral: HIIT exerciseParticipants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging
- Between 40-75 years old
- Body mass index of 30-50 kg/m2
- Endometrioid histology endometrial cancer
- Presumed clinically early stage disease (disease confined to uterus only)
Key exclusion criteria (11 listed)
- Meets American College of Sports Medicine Guidelines for physical activity (150 minutes / week)
- Currently doing HIIT
- Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
- Active diagnosis of psychosis or current uncontrolled substance abuse disorder
- Insulin-dependent diabetes
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 |
|---|---|---|
| HIIT exerciseHigh intensity interval training (4 to 6 sessions) prior to surgery | Behavioural | HIIT exercise |
Primary outcome
Change in Proliferative Markers in Endometrium Before and After HIIT Exercises
Time frame: 3 years
Change in Ki-67 proliferation values within the HIIT intervention group between the initial biopsy and the surgical biopsy. The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Victoria Bae-Jump, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT exercise in people with Endometrial Cancer, run by UNC Lineberger 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?
The sponsor lists 9 inclusion and 11 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 15 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Proliferative Markers in Endometrium Before and After HIIT Exercises (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2025.