Trial Outcomes & Findings for High Intensity Interval Training in Endometrial Cancer (NCT NCT04025229)

Last Updated: 2025-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

3 years

Results posted on

2025-10-15

Participant Flow

Participants enrolled were enrolled at a single North Carolina site between 09/23/2019 and 09/08/2022.

Thirty participants consented and began the study.

Participant milestones

Participant milestones
Measure	Control Arm No HIIT exercise prior to surgery	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.
Overall Study STARTED	10	20
Overall Study COMPLETED	9	16
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm No HIIT exercise prior to surgery	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.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Death	0	1
Overall Study Physician Decision	0	1

Baseline Characteristics

High Intensity Interval Training in Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=9 Participants No HIIT exercise prior to surgery.	HIIT Exercise n=16 Participants 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	Total n=25 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 5.3 • n=5 Participants	54.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	56.4 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	16 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Participants who started the study and provided a sample were included.

Outcome measures

Outcome measures
Measure	Control Arm- Baseline n=8 Participants 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 baseline.	Control Arm -At Surgery n=8 Participants 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.	HIIT- Baseline n=16 Participants The sample provided by participants who will perform HIIT exercises as instructed by the study team at baseline.	HIIT -At Surgery n=16 Participants The sample provided by participants who will perform HIIT exercises as instructed by the study team during surgery.
Change in Proliferative Markers in Endometrium Before and After HIIT Exercises	21.7 Percentage of cells expressing Ki67 Standard Deviation 12.2	15.1 Percentage of cells expressing Ki67 Standard Deviation 14.4	21.7 Percentage of cells expressing Ki67 Standard Deviation 12.2	20.2 Percentage of cells expressing Ki67 Standard Deviation 15.7

Adverse Events

HIIT Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Luz Andrea Cuaboy

UNC Lineberger Comprehensive Cancer Center

Phone: 1-919-843-1177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place