High Intensity Interval Training in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04025229
• Other study ID #: LCCC 1839
• Secondary ID: 1R21CA235029-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: September 8, 2025

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: September 8, 2025
• Est. primary completion date: September 8, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• HIIT exercise
High intensity interval training (4 to 6 sessions) prior to surgery

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proliferative markers in endometrium before and after HIIT exercises	Ki-67 values in biopsy samples	3 years