High Intensity Interval Training in Endometrial Cancer

UNC Lineberger Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Endometrial Cancer

Treatments: Behavioral: HIIT exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04025229

1R21CA235029-01 (U.S. NIH Grant/Contract)

LCCC 1839

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

HIIT exercise

Experimental group

Description:

Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery

Treatment:

Behavioral: HIIT exercise