Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Limited candidate pool
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Gastrointestinal Tract | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-Person Exercise Protocol | Other | — | UNRESOLVED |
| Virtual Exercise Protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- In-Person Exercise Protocol (IPEP)
- 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.
- interventionNames
- Other: In-Person Exercise Protocol
- type
- EXPERIMENTAL
- label
- Virtual Exercise Protocol (VEP)
- 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.
- interventionNames
- Other: Virtual Exercise Protocol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available