Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Study Overview
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Brief Summary
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Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

Detailed Description
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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.

Official Title
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Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.

Conditions
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Colon Cancer, Rectal Cancer, Frailty

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial with an intervention arm and a standard of care arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>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. | Other: Prehabilitation<br>* A minimum of four weeks of prehabilitation with exercise three times a week, protein and vitamin supplements, dietitian consultation and medical optimization prior to surgery.<br>|
| No Intervention: Standard of Care<br>Receives standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 15 | 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 | 3 days after surgery | 
| Changes in physical fitness prior to surgery | Changes in VO2 max between baseline and prior to surgery | Baseline, prior to surgery and 30 days after surgery | 
| Complications | Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome. | 30 days after surgery | 
| Changes in immunological function | Changes in immunological function measured by nanostring in blood and tumor (in the invasive front) | Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific quality of life - EORTC c30 | 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 | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery | 
| Disease specfic quality of life - EORTC c29 | 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. | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery | 
| Overall quality of life - SF-36 | 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. | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery | 
| Psychological health - Depression - PHQ-9 | 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 | the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery | 
| Psychological health - General anxiety - GAD-7 | 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 | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery | 
| Physical function (6-MWT) | 6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters | The day prior to surgery, 30 days after surgery, and 60 days after surgery | 
| Physical function (STS) | Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds. | The day prior to surgery, 30 days after surgery, and 60 days after surgery. | 
| Physical function (Stair climb test) | Stair climb test will be measured as the number of steps (17 mc in height) the paitent can rise in 30 secounds. | The day prior to surgery, 30 days after surgery, and 60 days after surgery | 
| Physical function (Leg extension test) | 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. | The day prior to surgery, 30 days after surgery, and 60 days after surgery | 
| Physical function (Hand grip strength) | Hand grip strength measured by hand-held dynanometer in kilograms. Measured 3 times on each hand and will use the maximum obtained. | The day prior to surgery, 30 days after surgery, and 60 days after surgery | 
| Nutritional status | Increase/decrease in total body weight in percent. | The day prior to surgery, 30 days after surgery, and 60 days after surgery | 
| Remission and cancer free survival | Remission and cancer free survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Colon cancer, WHO performance status, Rectal cancer, Exercise, Nutritional supplement