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

University of Pittsburgh

Status: Enrolling

Conditions: Esophageal Carcinoma; Esophageal Cancer

Treatments: Behavioral: Exercise and Nutrition; Behavioral: Usual Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06872515

STUDY24120028

Details and patient eligibility

About

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?

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Home-based prehabilitation exercise and nutrition (PRE)

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise and Nutrition

Usual Care (CONT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care Group