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

NCT06872515 | Recruiting

• 1 other identifier: STUDY24120028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Prehabilitation; Exercise; Esophageal cancer; Neoadjuvant chemotherapy; Pre-surgical exercise

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention

  Acceptability is defined as the proportion of approached participants who agree to participate and complete the baseline assessments and be randomized.

  From enrollment through surgical admission, up to 8 weeks

• Adherence to Intervention

  Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.

  From enrollment through surgical admission, up to 8 weeks

• Feasibility of Intervention

  The intervention will be considered feasible if 50% of participants complete approximately 70% of prescribed prehabilitation sessions prior to their surgical admission.

  From enrollment through surgical admission, up to 8 weeks

Secondary Outcomes (23)

• Six-minute walk test (6MWT)

  Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

• 2-Minute Step Test

  Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

• 30-second chair stand test (30CST)

  Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

• Timed-Up-and-Go (TUG) test

  Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

• Frail Scale

  Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy

Study Arms (2)

Home-based prehabilitation exercise and nutrition (PRE)

EXPERIMENTAL

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.

Behavioral: Exercise and Nutrition

Usual Care (CONT)

ACTIVE COMPARATOR

The CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.

Behavioral: Usual Care Group

Interventions

Exercise and Nutrition 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.

Home-based prehabilitation exercise and nutrition (PRE)

Usual Care Group 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.

Usual Care (CONT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Motor Activity

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Melanie Potiaumpai, PhD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Battistella, MA

CONTACT

412-353-9102; battistellac@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: July 16, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)