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

C

Célia Turco

Status

Completed

Conditions

Primary Liver Cancer
Liver Metastases
Secondary Liver Cancer

Treatments

Other: Standard Oncologic care
Behavioral: Interval training

Study type

Interventional

Funder types

Other

Identifiers

NCT03518632
2017-A02992-51

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

8 participants in 3 patient groups

Control group
Active Comparator group
Treatment:
Other: Standard Oncologic care
Interval training 1
Experimental group
Treatment:
Behavioral: Interval training
Interval training 2
Experimental group
Treatment:
Behavioral: Interval training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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