Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colon Cancer
- Sponsor
- Zealand University Hospital
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Complications
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Complications
Time Frame: 30 days after surgery
Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.
Changes in physical fitness prior to surgery
Time Frame: Baseline, prior to surgery and 30 days after surgery
Changes in VO2 max between baseline and prior to surgery
Changes in immunological function
Time Frame: Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen
Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)
Quality of Recovery 15
Time Frame: 3 days after surgery
Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome
Secondary Outcomes
- Disease specfic quality of life - EORTC c29(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Overall quality of life - SF-36(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Psychological health - Depression - PHQ-9(the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery)
- Disease specific quality of life - EORTC c30(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Physical function (Leg extension test)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Psychological health - General anxiety - GAD-7(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Physical function (STS)(The day prior to surgery, 30 days after surgery, and 60 days after surgery.)
- Physical function (Stair climb test)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Physical function (6-MWT)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Physical function (Hand grip strength)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Remission and cancer free survival(5 years)
- Nutritional status(The day prior to surgery, 30 days after surgery, and 60 days after surgery)