Clinical trial NCT04685759: Exercise Regimens and Neoadjuvant Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer of Gastrointestinal Tract
Keywords: Exercise Therapy
Cancer of Gastrointestinal Tract
Neoadjuvant Therapies
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with a primary GI tumor who complete neoadjuvant treatment and are cleared for surgical resection
timeFrame: Up to Week 12
Secondary outcomes:
measure: Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Timed Up and Go Test
timeFrame: 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.
measure: Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Stair Test
timeFrame: 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.
measure: Change in patient function as measured by Karnosfky Performance Status Scale
timeFrame: 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.
measure: Change in quality of life assessment
timeFrame: 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:
measure: Mean total Patient Satisfaction score of Telehealth Exercise Therapy
timeFrame: Immediately after administration of each exercise session
measure: Mean total Patient Satisfaction score of In-Person Exercise Therapy
timeFrame: Immediately after administration of each exercise session
Locations:
city: Fort Worth
country: United States
facility: UT Southwestern Medical Center, Moncrief Cancer Institute
state: Texas
city: Fort Worth
country: United States
facility: UT Southwestern Simmons Comprehensive Cancer Center - Fort Worth
state: Texas
Study officials:
affiliation: Jay.Lohrey@UTSouthwestern.edu
name: Jay Lohrey
role: PRINCIPAL_INVESTIGATOR
References: