Recruiting

Prehabilitation Program

Sponsor:

University of Pittsburgh

Code:

NCT06872515

Conditions

Esophageal Cancer

Esophageal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise and Nutrition

Usual Care Group

Study Details

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 ID

NCT06872515

Start date

Jul 16, 2025

Status verified date

May, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

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.

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 measure

  • Acceptability of Intervention [ Time Frame: From enrollment through surgical admission, up to 8 weeks ]
  • Adherence to Intervention [ Time Frame: From enrollment through surgical admission, up to 8 weeks ]
  • Feasibility of Intervention [ Time Frame: From enrollment through surgical admission, up to 8 weeks ]

Central Contacts and Locations

Central contacts

Cara Battistella, MA

412-353-9102battistellac@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Cara Battistella

412-353-9102battistellac@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-26.