Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients
- Conditions
- Rectal CancerFrailtyColon Cancer
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT04167436
- Lead Sponsor
- Zealand University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- Undergoing elective colorectal cancer surgery
- WHO performance status I and II
- Signed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation Patients receive multi-modal prehabilitation with exercise three times weekly, protein supplements, vitamin supplements, dietitian consultation and medical optimization prior to surgery. A minimum of four weeks.
- Primary Outcome Measures
Name Time Method Complications 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 Baseline, prior to surgery and 30 days after surgery Changes in VO2 max between baseline and prior to surgery
Changes in immunological function 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 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 Outcome Measures
Name Time Method 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 European Organisation for Research and Treatment of Cancer Questionaire c 29 (EORTC). The questionnaire contains 29 items, with a 4 point Likert scale for symptoms and 7 point Likert scale for quality of life and global health. For the 4 point Likert scale the higher the score the worse the outcome. For the 7 point likert scale higher values indicating a better outcome. Analysis will be performed for changes in individual symptoms and cumulative aggregation of scores will not be performed.
Overall quality of life - SF-36 the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery Short Form 36 question (SF-36) health questionnaire. The questionnaire contains eight domains: physical functioning, pain, limitations due to physical health problems, limitations due to personal or emotional problems, emotional well-being, social functioning, fatigue, and general health perceptions. Scores for each domain range from 0 to 100 and the analysis will be performed as mean difference between baseline and the following time frame. A higher value indicating a better outcome.
Psychological health - Depression - PHQ-9 the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery Patient Health Questionnaire 9 (PHQ-9) Depression test. The PHQ-9 have a maximum of 27 points and a minimum of 0. The outcome is point change between baseline and following time frame. A higher value indicating a worse outcome
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 European Organisation for Research and Treatment of Cancer Questionaire c 30 (EORTC c30). The EORTC c30 contains 6 domains which will each be assessed for mean changes in their cumulative score. The domains are physical function, role function, emotional function, pain, fatigue and global health. A higher value indicating a worse outcome
Physical function (Leg extension test) The day prior to surgery, 30 days after surgery, and 60 days after surgery Leg extension test will be measured by fixed dynaometer in newtons three times on each leg and the maximum for each leg used for analysis.
Psychological health - General anxiety - GAD-7 the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery General Anxiety Disorder 7-item (GAD-7). The questionnaire have a maximum of 21 points and a minium of 0. The outcome is the point change between baselin and the following time frame. A higher value indicating a worse outcome
Physical function (STS) The day prior to surgery, 30 days after surgery, and 60 days after surgery. Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds.
Physical function (Stair climb test) The day prior to surgery, 30 days after surgery, and 60 days after surgery Stair climb test will be measured as the number of steps (17 mc in height) the paitent can rise in 30 secounds.
Physical function (6-MWT) The day prior to surgery, 30 days after surgery, and 60 days after surgery 6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters
Physical function (Hand grip strength) The day prior to surgery, 30 days after surgery, and 60 days after surgery Hand grip strength measured by hand-held dynanometer in kilograms. Measured 3 times on each hand and will use the maximum obtained.
Remission and cancer free survival 5 years Remission and cancer free survival
Nutritional status The day prior to surgery, 30 days after surgery, and 60 days after surgery Increase/decrease in total body weight in percent.
Trial Locations
- Locations (2)
Slagelse Hospital
🇩🇰Slagelse, Danmark, Denmark
Zealand University Hospital
🇩🇰Køge, Danmark, Denmark