Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT06872515
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exercise and Nutrition — BEHAVIORALThe 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 — BEHAVIORALThe 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
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?
Key Dates
- Start date
- Jul 16, 2025
- Status verified
- May 2026
- Primary completion
- Apr 30, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Home-based prehabilitation exercise and nutrition (PRE)Interventions will include: * Up to 8 weeks of 3-5 times per week resistance training and 3-5 times per week of aerobic training. * Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
- Active Comparator: Usual Care (CONT)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 Measure
Acceptability of Intervention [ Time Frame: From enrollment through surgical admission, up to 8 weeks ]
Central Contacts
- Cara Battistella, MA412-353-9102
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 |
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