Prehabilitation on Fitness, Surgical Outcomes and Mitochondria Functionality in Patients With Esophageal Cancer

NCT04673968 | Unknown

• 1 other identifier: 201901758B0
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The most often reported complications of patients with resectable esophageal malignancies are pulmonary (25\~57%), which may cause increased intensive care unit utilization, prolonged length of hospital stay, increased mortality and medical expense. Also, neoadjuvant chemotherapy has a deleterious effect on patients' cardiopulmonary capacity, strength and muscle mass. Prehabilitation includes preoperative exercise training and nutrition management. The reporting outcome regarding whether it improves surgical outcomes is inconsistent. One of the reasons is that pulmonary complication tends to occur in patients with low cardiopulmonary fitness, but all studies included patients with all level of fitness. Most of the chemotherapy interferes with cell division to inhibit tumor growth but is also harmful to mitochondria functionality. For example, Cisplatin and Paclitaxel, commonly used in esophageal cancer, alter mitochondria function, caused by disruption of respiratory chain function and increased production of reactive oxygen species. However, it remains unclear their negative effects on the oxidative phosphorylation capacity of mitochondria (OXPHOS). Furthermore, whether prehabilitation reverses this negative effect is scarcely explored. Patients will be inquired to participate and randomized into prehabilitation or control group. The latter will undergo conventional therapy only, while the former will receive additional prehabilitation program. The prehabilitation program encompasses supervised and home-based aerobic, resistance training (large and inspiratory muscle) and nutrition management. The supervised exercise training will be performed right before or after the radiotherapy. Outcome variables are fitness-related testing \[the 1st year\], quality of life and surgical outcomes \[the 2nd year\] and mitochondria functionality (OXPHOS, membrane potential, matrix oxidant burden) \[the 3rd year\]. Evaluation is performed 3 times at baseline, before surgery and 4 weeks after surgery.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (4)

• Exercise capacity of all participants by Cardiopulmonary Exercise Test (CPET)

  Cardiopulmonary Exercise Test

  three years

• Exercise capacity of fitness-related parameters: 6-minute walk distance

  Detection of 6-minute walk distance in meters

  three years

• Exercise capacity of fitness-related parameters: hand grip

  Detection of hand grip strength in kilograms

  three years

• Body composition

  Body composition analysis

  three years

Secondary Outcomes (3)

• Surgical outcomes of inpatient days

  three years

• Complications outcomes

  three years

• Mitochondria functionality

  three years

Study Arms (2)

prehabilitation (P)

ACTIVE COMPARATOR

inhospital exercise training 5 times/week, 5\~6 weeks during nCRT (neoadjuvant chemoraiotherapy); home exercise 5 times/week, 5\~6 weeks, between completion of nCRT and before surgery

Other: prehabilitation

control group (C)

NO INTERVENTION

no prehabilitation

Interventions

prehabilitation OTHER

inhospital exercise training 5 times/week, 5\~6 weeks during nCRT; home exercise 5 times/week, 5\~6 weeks, between completion of nCRT and before surgery

prehabilitation (P)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nonmetastatic esophageal cancer patients.
• V'O2 \< 21ml/min/kg
• abnormality on spirometry.

You may not qualify if:

• Resting heart rate greater than 100 beats per minute
• Atrial fibrillation or flutter
• Poor control of high blood pressure or diabetes
• Patients with peripheral arterial occlusive disease
• Patients with end-stage renal disease
• Patients receiving anticoagulant therapy
• Neurological instability

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shu-Chun Huang, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Chun Huang, MD, PhD

CONTACT

+88633281200; mr7171@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 17, 2020
• Study Start: February 25, 2020
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-08

Locations

TW (1)