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NCT Number: NCT03518632

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

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.

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Key information

Conditions

Primary Liver Cancer Adenocarcinoma Behavior Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Metastases Liver Neoplasms Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Secondary Liver Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chirurgie digestive, viscérale et cancérologique

Besançon, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval Training

Behavioral

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 care

Other

Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative complications with the Dindo Clavien classification :

    Time frame: One month after surgery

    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).

  2. Intensive care stay :

    Time frame: One month after surgery

    Postoperative intensive care stay will be evaluated (number of days).

  3. Changes of Hepatokines plasmatic concentrations :

    Time frame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks

    Fetuin A (ng/mL) concentrations will be analyzed.

  4. Hepatokines plasmatic concentrations :

    Time frame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks

    Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed.

  5. Changes in Physical activity level :

    Time frame: Comparison between baseline, after the 6 weeks' program

    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.

  6. Changes in Quality of life :

    Time frame: Comparison between baseline, after the 6 weeks' program

    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.

  7. Changes in Fatigue :

    Time frame: Comparison between baseline, after the 6 weeks' program

    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.

Sponsors and collaborators

Lead sponsor

Célia Turco

Other

Registry information

Official study title

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

Acronym: APACHE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2018
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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