Exercise Regimens and Neoadjuvant Chemotherapy

NCT04685759 | Withdrawn DMC

• 1 other identifier: STU-2020-0948
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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. 3.To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.

Conditions

Cancer of Gastrointestinal Tract

Keywords

Exercise Therapy; Cancer of Gastrointestinal Tract; Neoadjuvant Therapies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Timed Up and Go Test

  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

  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

  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

  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 Outcomes (2)

• Mean total Patient Satisfaction score of Telehealth Exercise Therapy

  Immediately after administration of each exercise session

• Mean total Patient Satisfaction score of In-Person Exercise Therapy

  Immediately after administration of each exercise session

Study Arms (2)

In-Person Exercise Protocol (IPEP)

ACTIVE COMPARATOR

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

Virtual Exercise Protocol (VEP)

EXPERIMENTAL

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

Interventions

In-Person Exercise Protocol OTHER

Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.

In-Person Exercise Protocol (IPEP)

Virtual Exercise Protocol OTHER

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.

Virtual Exercise Protocol (VEP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

UT Southwestern Medical Center, Moncrief Cancer Institute

Fort Worth, Texas, 76104, United States

Location

UT Southwestern Simmons Comprehensive Cancer Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jay Lohrey

  Jay.Lohrey@UTSouthwestern.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine / Harold S. Simmons Comprehensive Cancer Center

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 28, 2020
• Study Start: April 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

US (2)