NCT06872515 · University of Pittsburgh
Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)
What this study is about
The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery.
View original scientific description
The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise and nutrition intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise and nutrition before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups.
Interventions
BEHAVIORAL
Exercise and Nutrition
The exercise and nutrition intervention will last up to 8 weeks and will include: * 3-5 times per week of resistance training and 3-5 times per week of aerobic training. The prescribed exercise will be personalized based on the participant's baseline functionality. * Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
BEHAVIORAL
Usual Care Group
The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.
Primary outcome measures
Acceptability of Intervention
Time frame: From enrollment through surgical admission, up to 8 weeks
Acceptability is defined as the proportion of approached participants who agree to participate and complete the baseline assessments and be randomized.
Adherence to Intervention
Time frame: From enrollment through surgical admission, up to 8 weeks
Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.
Feasibility of Intervention
Time frame: From enrollment through surgical admission, up to 8 weeks
The intervention will be considered feasible if 50% of participants complete approximately 70% of prescribed prehabilitation sessions prior to their surgical admission.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women, age ≥ 18 years old
- Diagnosed with esophageal cancer
- Identified as esophagectomy surgery candidates at Hillman Cancer Center, UPMC Shadyside, or UPMC Passavant
- ≥ 2 weeks until scheduled esophagectomy
- ECOG Performance Status Scale score of ≤ 2
- Ability to provide written informed consent
- Ability to understand, speak, and read English.
Exclusion criteria
- Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
- Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
- Receiving non-esophagectomy related chemotherapy and/or radiotherapy
- Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse
Where
- Pittsburgh, Pennsylvania
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations