Colon Cancer, Frailty, Rectal Cancer
Conditions
Keywords
Prehabilitation, Colon cancer, WHO performance status, Rectal cancer, Exercise, Nutritional supplement
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.
Interventions
OTHERPrehabilitation
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.
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.
Intervention model description
Randomized Clinical Trial with an intervention arm and a standard of care arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (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 (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. |
| 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 (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. |
| Nutritional status | The day prior to surgery, 30 days after surgery, and 60 days after surgery | Increase/decrease in total body weight in percent. |
| Remission and cancer free survival | 5 years | Remission and cancer free survival |
| 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. |
| 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 |
Countries
Denmark
Outcome results
None listed