Exercise Regimens and Neoadjuvant Chemotherapy

The University of Texas System (UT)

Status: Withdrawn

Conditions: Cancer of Gastrointestinal Tract

Treatments: Other: In-Person Exercise Protocol; Other: Virtual Exercise Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04685759

STU-2020-0948

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of exercise therapy for patients undergoing neoadjuvant chemotherapy for primary gastrointestinal (GI) tract cancer, providing a reproducible exercise regimen designed to improve or preserve aerobic fitness, strength, and quality of life. In addition, this study will address shifts in healthcare delivery needed as a result of the coronavirus disease 2019 (COVID-19) pandemic, evaluating the effectiveness of telehealth instruction as a method for exercise therapy.

The study hypotheses are:

1. To evaluate the effectiveness of exercise therapy for cancer patients undergoing neoadjuvant treatment when delivered via telehealth, as compared to an in-person setting.
2. To assess stair test instrumentation, previously validated in a healthy population, as a measure to gauge health status in cancer patients undergoing neoadjuvant treatment.
3. To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.

Full description

After being informed about the study and potential risks and benefits, all patients meeting inclusion criteria who provide written informed consent will be randomized at the time of enrollment to one of two cohorts engaged in a standardized exercise regimen based on delivery method, either in-person or via telehealth. Patient function will be assessed using the Timed Up and Go (TUG) test; Stairs Test; which evaluates aerobic ability, resistance, agility, balance, and posture; and given a score on the Karnofsky Performance Status Scale. Patient quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) survey. Outcomes for the cohorts will be compared over time.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 75 years of age
• Primary language is either English or Spanish
• Primary cancer diagnosis of GI cancer
• Undergoing neoadjuvant chemotherapy prior to surgical resection.
• Patients are being treated by medical oncologist at Simmons Cancer Center at Moncrief Cancer Institute in Fort Worth

Exclusion criteria

• Patient has had systemic cancer treatment in the past year
• Patient initiated neoadjuvant chemotherapy treatment prior to study enrollment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

In-Person Exercise Protocol (IPEP)

Active Comparator group

Description:

This group will receive exercise instruction and monitoring in-person from the certified Cancer Exercise Trainer (CET) in the gym facility at Moncrief Cancer Institute (MCI). Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.

Treatment:

Other: In-Person Exercise Protocol

Virtual Exercise Protocol (VEP)

Experimental group

Description:

This group will receive exercise instruction and monitoring from the CET via telehealth sessions at home. Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.

Treatment:

Other: Virtual Exercise Protocol