Exercise Regimens and Neoadjuvant Chemotherapy

Assessing the Non-inferiority of Virtual vs. In-person Concurrent Exercise Regimens in Patients Receiving Neoadjuvant Therapy Prior to Surgical Resection of a Primary GI Tumor

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer of Gastrointestinal Tract
• Intervention / Treatment: Other: In-Person Exercise Protocol; Other: Virtual Exercise Protocol

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76104
      • UT Southwestern Medical Center, Moncrief Cancer Institute
    • Fort Worth, Texas, United States, 76104
      • UT Southwestern Simmons Comprehensive Cancer Center - Fort Worth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-Person Exercise Protocol (IPEP); 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.	Other: In-Person Exercise Protocol; Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.
Experimental: Virtual Exercise Protocol (VEP); 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.	Other: Virtual Exercise Protocol; Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes each virtual session. A TheraBand (resistance band) will be provided to patients in this group to be used for resistance and flexibility training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a primary GI tumor who complete neoadjuvant treatment and are cleared for surgical resection	The primary efficacy endpoint is the proportion of patients who complete neoadjuvant treatment and surgical resection for a primary GI tumor. All individuals failing to achieve the success definition described above will be considered treatment failures. All individuals who drop out of the study or discontinue in the exercise program prior to completion of neoadjuvant chemotherapy (NAC) and surgical resection will be considered treatment failures. Patients will be evaluated for surgical resection at completion of NAC (Week 8-12).	Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Timed Up and Go Test	Analyses of change from baseline will be measured by the Timed Up and Go Test (TUG). Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The TUG test is a validated measurement of patient agility and balance, in addition to assessing if patient is a fall risk. Patients will be timed in seconds on standing up from a seated position, walking to a 3 meter line, and returning to the chair in a seated position at their regular pace without assistance from another person. Reference values for ages 60-99 years range from 7.1-12.7 seconds, with additional cut-off values predictive of falls. Results correlate with gait speed, balance, functional level, the ability to go out, and can follow change over time.	Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Stair Test	Analyses of change from baseline will be measured by the Stair Test. Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The Stair test is a validated measurement of aerobic ability, resistance, agility, balance, and posture. Patients will be timed in seconds to climb 2 flights of stairs in a constant rhythm, one step at a time. Patients will not be allowed to stop at any point during the climb or use side railings for support. The cancer exercise trainer will accompany each subject to ensure protocol compliance and safety. Maximal oxygen intake (VO2max) will be calculated for each patient and compared against predicted VO2 calculations based on gender, age, BMI, and heart rate at end of the stair climb.	Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
Change in patient function as measured by Karnosfky Performance Status Scale	The Karnosfky Performance Status Scale measures the ability of cancer patients to perform ordinary tasks. Possible scores range from 0 to 100 by increments of 10, with higher scores indicating that patients are better able to carry out daily activities. Patient function will be assessed using the Timed Up and Go (TUG) test, Stairs Test, which evaluate patient's aerobic ability, resistance, agility, balance, and posture, as well as the Karnosfky Performance Status Scale. Patient quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) survey. All assessments will be completed at baseline, prior to the initial exercise therapy session, at midpoint, and at the final session prior to surgery, as well as 30 days post-surgery. Exercise therapy will be deemed effective by preventing a reduction to patient function and quality of life over the course of enrollment in the study.	Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
Change in quality of life assessment	Analyses of change from baseline for quality of life will be measured by the Functional Assessment of Cancer Therapy - General (FACT-G) survey. Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The FACT-G survey measures patient quality of life. This validated survey contains 27 items measured by a 5 point Likert-type scale in 4 domains relevant to cancer patients: Physical, Social, Emotional, and Functional well-being. Possible scores range from 0 to 108, with higher scores indicating a better quality of life.	Baseline prior to initial exercise therapy session (Week 1), midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal (Week 13, Up to Week 17).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean total Patient Satisfaction score of Telehealth Exercise Therapy	The Virtual Exercise Protocol Satisfaction Survey Scale (VEPSS1) measures patient satisfaction with the service delivery method of the exercise intervention. This is a researcher-designed survey for use in this study. Possible scores range from 0 to 20, with higher scores indicating a better outcome. The VEPSS1 will be used for telehealth cohort only. Satisfaction will be summarize as a continuous score for the participant populations. Median and interquartile ranges of the score will be recorded. Differences in comprehension will be measured between the In-Person Exercise Protocol Satisfaction Survey Scale and the VEPSS1.	Immediately after administration of each exercise session
Mean total Patient Satisfaction score of In-Person Exercise Therapy	The In-Person Exercise Protocol Satisfaction Survey Scale (IPEPSS1) measures patient satisfaction with the in-person service delivery method of the exercise intervention. This is a researcher-designed survey for use in this study. Possible scores range from 0 to 20, with higher scores indicating a better outcome. The IPEPSS1 will be used for in-person exercise cohort only. Satisfaction will be summarize as a continuous score for the participant populations. Median and interquartile ranges of the score will be recorded. Differences in comprehension will be measured between the IPEPSS1 and the VEPSS1.	Immediately after administration of each exercise session

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Jay Lohrey, Jay.Lohrey@UTSouthwestern.edu

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Exercise Therapy; Cancer of Gastrointestinal Tract; Neoadjuvant Therapies
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: STU-2020-0948

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No