Clinical trial NCT04167436: Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients
Official title: Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colon Cancer
Rectal Cancer
Frailty
Keywords: Prehabilitation
Colon cancer
WHO performance status
Rectal cancer
Exercise
Nutritional supplement
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with an intervention arm and a standard of care arm.
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

Detailed description: Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive

The study is a part of the PREHAB study which is performed in collaboration with international centers.

The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective colorectal cancer surgery
* WHO performance status I and II
* Signed consent

Exclusion Criteria:

* Known metastatic disease
* Unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments.
* ASA 4 or 5 (American Society of Anesthesiologist Classification)
* Neoadjuvant chemo- or radiation therapy
* Renal failure III B or higher
* Illiteracy or unable to write or understand Danish
* Cognitive disabilities, which affects adherence e.g. severe dementia (MMSE score ≤17).
* Withdrawal of consent.

Primary outcomes:
measure: Quality of Recovery 15
timeFrame: 3 days after surgery
measure: Changes in physical fitness prior to surgery
timeFrame: Baseline, prior to surgery and 30 days after surgery
measure: Complications
timeFrame: 30 days after surgery
measure: Changes in immunological function
timeFrame: Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen
Secondary outcomes:
measure: Disease specific quality of life - EORTC c30
timeFrame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
measure: Disease specfic quality of life - EORTC c29
timeFrame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
measure: Overall quality of life - SF-36
timeFrame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
measure: Psychological health - Depression - PHQ-9
timeFrame: the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery
measure: Psychological health - General anxiety - GAD-7
timeFrame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
measure: Physical function (6-MWT)
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
measure: Physical function (STS)
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery.
measure: Physical function (Stair climb test)
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
measure: Physical function (Leg extension test)
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
measure: Physical function (Hand grip strength)
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
measure: Nutritional status
timeFrame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
measure: Remission and cancer free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Danmark
city: Slagelse
country: Denmark
facility: Slagelse Hospital
state: Danmark
Study officials:
References:
citation: Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
citation: Bojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8.