Clinical trial NCT06872515: Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)
Official title: Impact of Prehabilitation in Oncology Via Exercise- Esophageal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Esophageal Carcinoma
Keywords: Prehabilitation
Exercise
Esophageal cancer
Neoadjuvant chemotherapy
Pre-surgical exercise
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to (1) determine the feasibility of a prehabilitation exercise program (exercise before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise program will include resistance and aerobic training during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise 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 before surgery for esophageal cancer feasible and acceptable to patients?
* How does exercise before surgery change physical function and psychosocial health?
* What are important pre-surgical needs for adults with esophageal cancer?


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
* Currently completing, or completed Neoadjuvant chemotherapy
* 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

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: From enrollment through surgical admission, up to 8 weeks
measure: Adherence to Intervention
timeFrame: From enrollment through surgical admission, up to 8 weeks
measure: Feasibility of Intervention
timeFrame: From enrollment through surgical admission, up to 8 weeks
Secondary outcomes:
measure: Six-minute walk test (6MWT)
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: 30-second chair stand test (30CST)
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Timed-Up-and-Go (TUG) test
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Handgrip assessment
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Actigraph accelerometry
timeFrame: Baseline, 2 Weeks post esophagectomy, and 4 Months post esophagectomy
measure: SARC-F Sarcopenia scale
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Carbon Monoxide (CO) assessment
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Fried Frailty Index for physical frailty
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Demographics
timeFrame: Baseline
measure: Injury History Survey (EX Cohort only)
timeFrame: Time of Admission
measure: EORTC QLQ-C30 Quality of Life (QoL)
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Multidimensional Fatigue Inventory
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Godin Leisure Time Exercise
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: PROMIS Smoking Assessment
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: PROMIS Cognitive Function- Short Form
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: PG-SGA Nutrition Assessment- Short Form
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Healthcare utilization
timeFrame: Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy
measure: Pre-Treatment Resources Assessment
timeFrame: Baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Melanie Potiaumpai, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: