What this study is
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.
The main questions of this trials are:
- Is exercise and nutrition supplementation before surgery for esophageal cancer feasible and acceptable to patients?
- How does exercise and nutrition supplementation before surgery change physical function and psychosocial health?
- What are important pre-surgical needs for adults with esophageal cancer?
What's being tested
- Exercise and Nutrition
Intervention · BEHAVIORAL
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.
- Usual Care Group
Intervention · BEHAVIORAL
The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.
Study details
- Official title
- Impact of Prehabilitation in Oncology Via Exercise- Esophageal
- Sponsor
- University of Pittsburgh
- Conditions
- Esophageal Cancer · Esophageal Carcinoma
- Enrolling
- 20 people
- Starts
- 2025-07-16
- Est. completion
- 2027-10-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
- Cara Battistella · Contact412-353-9102battistellac@upmc.edu
Recruiting
Study team
Sponsor
University of Pittsburgh
Study ID STUDY24120028
Principal investigator
Melanie Potiaumpai, PhD, MPH
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.