Endometrial Cancer
Conditions
Brief 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
Detailed description
Primary Objectives: 1\. 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.
Interventions
BEHAVIORALHIIT exercise
High intensity interval training (4 to 6 sessions) prior to surgery
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will complete HIIT training prior to surgery
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Proliferative Markers in Endometrium Before and After HIIT Exercises | 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. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled were enrolled at a single North Carolina site between 09/23/2019 and 09/08/2022.
Pre-assignment details
Thirty participants consented and began the study.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm No HIIT exercise prior to surgery. | 9 |
| HIIT Exercise Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery.
HIIT exercise: High-intensity interval training (4 to 6 sessions) prior to surgery | 16 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Control Arm | Total | HIIT Exercise |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 5.3 | 56.4 years STANDARD_DEVIATION 7.4 | 54.9 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 24 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 20 Participants | 12 Participants |
| Region of Enrollment United States | 9 participants | 25 participants | 16 participants |
| Sex: Female, Male Female | 9 Participants | 25 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 3 years
Population: Participants who started the study and provided a sample were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm- Baseline | Change in Proliferative Markers in Endometrium Before and After HIIT Exercises | 21.7 Percentage of cells expressing Ki67 | Standard Deviation 12.2 |
| Control Arm -At Surgery | Change in Proliferative Markers in Endometrium Before and After HIIT Exercises | 15.1 Percentage of cells expressing Ki67 | Standard Deviation 14.4 |
| HIIT- Baseline | Change in Proliferative Markers in Endometrium Before and After HIIT Exercises | 21.7 Percentage of cells expressing Ki67 | Standard Deviation 12.2 |
| HIIT -At Surgery | Change in Proliferative Markers in Endometrium Before and After HIIT Exercises | 20.2 Percentage of cells expressing Ki67 | Standard Deviation 15.7 |