Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Linkoeping University0 sites90 target enrollmentMarch 2022

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Linkoeping University
Enrollment: 90
Primary Endpoint: 6 minute walk test (6mwt)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.

Registry

clinicaltrials.gov

Start Date

March 2022

End Date

December 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Linkoeping University

Responsible Party

Principal Investigator

Bergthor Björnsson

Associate Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

•Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.

Exclusion Criteria

•Surgery is scheduled in less than 12 weeks.
•Paralytic or completely immobilized patient, condition making physical training impractical.
•Cognitive disability making participation impossible.
•Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.

Outcomes

Primary Outcomes

6 minute walk test (6mwt)

Time Frame: 12 weeks

6 minute walk test (6mwt)

Secondary Outcomes

Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)(12 weeks)
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)(90 day after surgery)
30 s chair stand test(12 weeks)
Test of hand grip strength(12 weeks)
Cardiopulmonary exercise test with ventilatory gas analysis(12 weeks)
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)(12 weeks)
Weekly alcohol consumption(12 weeks)
Sum of all complications in each patient (comprehensive complication index, CCI)(90d after surgery)
Clinical Frailty Scale(12 weeks)
International Physical Activity Questionnaire(12 weeks)
Length of hospitalization(90d after surgery)
Grade of sarcopenia(12 weeks)
Incremental cost-effectiveness ratio(2 years after surgery)
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria(12 weeks)
Overall survival(5 years)
4-week point prevalence of smoking abstinence (among baseline smokers)(12 weeks)
Episodes of heavy drinking per month(12 weeks)
The most severe complication occurring(90d after surgery)
Time to functional recovery of physical status as compared to baseline values(90d after surgery)
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)(90 days)
Quality of Life (QoL)(2 years after surgery)
Proportion of patients not able to receive all treatment despite no dissemination of disease(90 day after surgery)