Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)

NCT ID: NCT06872515

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-10-01

Brief Summary

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?

Conditions

Esophageal Cancer; Esophageal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise and Nutrition

Intervention Type: 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 (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.

Group Type: ACTIVE_COMPARATOR

Usual Care Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women, age ≥ 18 years old
• Diagnosed with esophageal cancer
• Identified as esophagectomy surgery candidates at Hillman Cancer Center or UPMC Shadyside
• ≥ 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Melanie Potiaumpai

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie Potiaumpai, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cara Battistella, MA

Role: CONTACT

battistellac@upmc.edu

412-353-9102

Facility Contacts

Cara Battistella

Role: primary

battistellac@upmc.edu

412-353-9102

Other Identifiers

STUDY24120028

Identifier Type: -

Identifier Source: org_study_id