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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA235029-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT exercise | Experimental | Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT exercise | Behavioral | High intensity interval training (4 to 6 sessions) prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
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Inclusion Criteria:
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:
This study recruits women with endometrial cancer
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Bae-Jump, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
Thirty participants consented and began the study.
Participants enrolled were enrolled at a single North Carolina site between 09/23/2019 and 09/08/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | No HIIT exercise prior to surgery |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | No HIIT exercise prior to surgery. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who started the study and provided a sample were included. | Posted | Mean | Standard Deviation | Percentage of cells expressing Ki67 | 3 years |
|
Not available. The protocol does not require adverse event assessment.
The protocol did not require adverse event (AE) assessment; therefore, AE data were not systematically collected. However, if participants reported discontinuation from the study due to an adverse event or death, these were recorded as non-specific events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luz Andrea Cuaboy | UNC Lineberger Comprehensive Cancer Center | 1-919-843-1177 | luz_cuaboy@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2021 | Jun 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Participants will complete HIIT training prior to surgery
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| Death |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm -At Surgery | The sample provided by participants who will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery at surgery. |
| OG002 | HIIT- Baseline | The sample provided by participants who will perform HIIT exercises as instructed by the study team at baseline. |
| OG003 | HIIT -At Surgery | The sample provided by participants who will perform HIIT exercises as instructed by the study team during surgery. |
|
|
| 1 |
| 30 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |