Primary Liver CancerAPACHENCT03518632
Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)
A study testing Interval training and Standard Oncologic care in people with Primary Liver Cancer and Secondary Liver Cancer, run by Célia Turco at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer, Secondary Liver Cancer, Liver Metastases
- What is being tested?
- Interval training and Standard Oncologic care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Interval training, Standard Oncologic care
- Keywords
- Exercise, Adapted physical activity, preoperative, liver resection, hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval trainingBehavioural
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.
Standard Oncologic careOther
Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Standard Oncologic care |
| Interval training 1 | Experimental | Not described Receives: Behavioral: Interval training |
| Interval training 2 | Experimental | Not described Receives: Behavioral: Interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (7)
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).
Measured: One month after surgery
Intensive care stay :
Postoperative intensive care stay will be evaluated (number of days).
Measured: One month after surgery
Changes of Hepatokines plasmatic concentrations :
Fetuin A (ng/mL) concentrations will be analyzed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Comparison between baseline, after the 6 weeks' program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start27 Mar 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Célia Turco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Célia Turco, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518632
- Sponsor's protocol ID
- 2017-A02992-51
- Acronym
- APACHE
- Status last verified
- Jul 2020
- First submitted
- 6 Apr 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer
- ClinicalTrials.gov ID
- NCT03518632
- Acronym / sponsor ID
- APACHE / 2017-A02992-51
- Keywords
- Exercise, Adapted physical activity, preoperative, liver resection, hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Célia TurcoUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard Oncologic care |
| Interval training 1 | Experimental | Behavioral: Interval training |
| Interval training 2 | Experimental | Behavioral: Interval training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval trainingPatients 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. | Behavioural | Interval training 1, Interval training 2 |
| Standard Oncologic carePatients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises. | Other | Control group |
Primary outcome
Change of Oxgen consumption at anaerobic threshold :
Time frame: 6 weeks
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
7 secondary outcomes
Postoperative complications with the Dindo Clavien classification :
Time frame: One month after surgery
Intensive care stay :
Time frame: One month after surgery
Changes of Hepatokines plasmatic concentrations :
Time frame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Hepatokines plasmatic concentrations :
Time frame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Changes in Physical activity level :
Time frame: Comparison between baseline, after the 6 weeks' program
Changes in Quality of life :
Time frame: Comparison between baseline, after the 6 weeks' program
Changes in Fatigue :
Time frame: Comparison between baseline, after the 6 weeks' program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval training and Standard Oncologic care in people with Primary Liver Cancer and Secondary Liver Cancer, run by Célia Turco at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Oxgen consumption at anaerobic threshold : (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.