Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE) (APACHE)

Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer

The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.

Study Overview

• Status: Completed
• Conditions: Primary Liver Cancer; Liver Metastases; Secondary Liver Cancer
• Intervention / Treatment: Other: Standard Oncologic care; Behavioral: Interval training

Detailed Description

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with primary or secondary liver cancer undergoing hepatectomy. Preoperative exercise programs have been shown to be effective in other cancer populations, but have been poorly studied in patients with liver cancer. For these patients, it remains unclear what the optimal composition of such programs should be and how they should be delivered. Outcome measures in this study will include preoperative outcomes (oxygen consumption, quality of life, fatigue and physical activity level, anthropometric measures, plasma concentrations of hepatokines) and postoperative outcomes (length of hospital stay and postoperative complications).

After the study is explained and consent obtained, subjects will be tested on a submaximal exercise on cycloergometer with gas exchanges analysis and with pre and post blood test. Then, they will answer various questionnaires assessing physical activity, quality of life and fatigue.

Patients scheduled for liver resection will be randomized to one of two groups. The first group (experimental group) will be subdivided into two groups: interval training 1 and interval training 2, which differentiate themselves by two different intensities.The second group (control group) will receive standard care.

The prehabilitation program will last 6 weeks with 3 sessions per week and will consist in two interval training programs on a cycloergometer with two different intensities.

One month after surgery, peri and postoperative complications will be noted.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Chirurgie digestive, viscérale et cancérologique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged >18 years old.
• Patients with primary liver cancer, biliary tract cancer, liver metastasis endorsed in the University Hospital of Besancon
• No opposition of patients
• Join a French social security or receiving such a scheme

Exclusion Criteria:

• Legal incapacity or limited legal capacity
• Patients being in the disqualification of another study or under the national register of volunteers
• Patients unlikely to cooperate or anticipated low cooperation
• Patients with a maximal oxygen consumption above 35 ml/min/kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Standard Oncologic care; Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.
Experimental: Interval training 1	Behavioral: Interval training; Patients in experimental group will perform a 6 weeks' physical activity program with 3 sessions per week. Physical activity intervention will consist in 2 different interval training programs on cycloergometer: Interval training 1 and Interval training 2, with a difference in exercise intensities.
Experimental: Interval training 2	Behavioral: Interval training; Patients in experimental group will perform a 6 weeks' physical activity program with 3 sessions per week. Physical activity intervention will consist in 2 different interval training programs on cycloergometer: Interval training 1 and Interval training 2, with a difference in exercise intensities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Oxgen consumption at anaerobic threshold :	Oxygen consumption at anaerobic threshold will be assessed at baseline and at the end of the 6 weeks' program with a submaximal exercise performed on cycloergometer	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications with the Dindo Clavien classification :	Postoperative complications will be assessed using the Dindo Clavien classification which consists in a 7 grades classification (I, II, IIIa, IIIb, IVa, IVb and V).	One month after surgery
Intensive care stay :	Postoperative intensive care stay will be evaluated (number of days).	One month after surgery
Changes of Hepatokines plasmatic concentrations :	Fetuin A (ng/mL) concentrations will be analyzed.	Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Hepatokines plasmatic concentrations :	Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed.	Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Changes in Physical activity level :	Physical activity level will be measured using the long-form of the International Physical Activity Questionnaire (IPAQ). It consist in a description of the physical activity level by assessing 5 activity domains during the 7 last days. Physical activity level is expressed in Metabolic Equivalent Tasks (METs). It enables to classify patients in 3 categories : low physical activity level, moderate physical activity level and high physical activity level.	Comparison between baseline, after the 6 weeks' program
Changes in Quality of life :	Health related quality of life will be measured with the EORTC Quality of Life Questionnaire QLQ-C30 which is a cancer specific questionnaire. It consists in 30 items to measure 15 dimensions of quality of life. It generates a score between 0 and 100. A higher score means a higher quality of life level.	Comparison between baseline, after the 6 weeks' program
Changes in Fatigue :	Fatigue will be measured with the Quality of Life Questionnaire QLQ-FA12 which enables to assess cancer related fatigue. It consists in 12 items to measure 5 dimension go health related fatigue. It generates a score between 0 and 100. A higher score means a higher fatigue level.	Comparison between baseline, after the 6 weeks' program

Collaborators and Investigators

• Sponsor: Célia Turco

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; liver resection; preoperative; hepatectomy; Adapted physical activity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2017-A02992-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No