Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE) (APACHE)
Primary Purpose
Primary Liver Cancer, Secondary Liver Cancer, Liver Metastases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interval training
Standard Oncologic care
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Liver Cancer focused on measuring Exercise, Adapted physical activity, preoperative, liver resection, hepatectomy
Eligibility Criteria
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
Sites / Locations
- Chirurgie digestive, viscérale et cancérologique
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Interval training 1
Interval training 2
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Intensive care stay :
Postoperative intensive care stay will be evaluated (number of days).
Changes of Hepatokines plasmatic concentrations :
Fetuin A (ng/mL) concentrations will be analyzed.
Hepatokines plasmatic concentrations :
Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03518632
Brief Title
Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)
Acronym
APACHE
Official Title
Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Célia Turco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Liver Cancer, Secondary Liver Cancer, Liver Metastases
Keywords
Exercise, Adapted physical activity, preoperative, liver resection, hepatectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Interval training 1
Arm Type
Experimental
Arm Title
Interval training 2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Interval training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Oncologic care
Intervention Description
Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.
Primary Outcome Measure Information:
Title
Change of Oxgen consumption at anaerobic threshold :
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Postoperative complications with the Dindo Clavien classification :
Description
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).
Time Frame
One month after surgery
Title
Intensive care stay :
Description
Postoperative intensive care stay will be evaluated (number of days).
Time Frame
One month after surgery
Title
Changes of Hepatokines plasmatic concentrations :
Description
Fetuin A (ng/mL) concentrations will be analyzed.
Time Frame
Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Title
Hepatokines plasmatic concentrations :
Description
Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed.
Time Frame
Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Title
Changes in Physical activity level :
Description
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.
Time Frame
Comparison between baseline, after the 6 weeks' program
Title
Changes in Quality of life :
Description
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.
Time Frame
Comparison between baseline, after the 6 weeks' program
Title
Changes in Fatigue :
Description
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.
Time Frame
Comparison between baseline, after the 6 weeks' program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chirurgie digestive, viscérale et cancérologique
City
Besançon
ZIP/Postal Code
25000
Country
France
12. IPD Sharing Statement
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Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)
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