Clinical trial NCT05270577: Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
Official title: Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: 6 minute walk test (6mwt)
timeFrame: 12 weeks
Secondary outcomes:
measure: 30 s chair stand test
timeFrame: 12 weeks
measure: Test of hand grip strength
timeFrame: 12 weeks
measure: International Physical Activity Questionnaire
timeFrame: 12 weeks
measure: Cardiopulmonary exercise test with ventilatory gas analysis
timeFrame: 12 weeks
measure: The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
timeFrame: 12 weeks
measure: Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
timeFrame: 12 weeks
measure: Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
timeFrame: 12 weeks
measure: 4-week point prevalence of smoking abstinence (among baseline smokers)
timeFrame: 12 weeks
measure: Weekly alcohol consumption
timeFrame: 12 weeks
measure: Episodes of heavy drinking per month
timeFrame: 12 weeks
measure: The most severe complication occurring
timeFrame: 90d after surgery
measure: Sum of all complications in each patient (comprehensive complication index, CCI)
timeFrame: 90d after surgery
measure: Length of hospitalization
timeFrame: 90d after surgery
measure: Time to functional recovery of physical status as compared to baseline values
timeFrame: 90d after surgery
measure: Clinical Frailty Scale
timeFrame: 12 weeks
measure: Grade of sarcopenia
timeFrame: 12 weeks
measure: 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)
timeFrame: 90 days
measure: Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
timeFrame: 90 day after surgery
measure: Proportion of patients not able to receive all treatment despite no dissemination of disease
timeFrame: 90 day after surgery
measure: Overall survival
timeFrame: 5 years
measure: Quality of Life (QoL)
timeFrame: 2 years after surgery
measure: Incremental cost-effectiveness ratio
timeFrame: 2 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Bergthor Björnsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: