Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167436
• Other study ID #: REG-040-2017
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2022
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Frailty
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Prehabilitation
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.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge	Danmark
Denmark	Slagelse Hospital	Slagelse	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Nutritional status	Increase/decrease in total body weight in percent.	The day prior to surgery, 30 days after surgery, and 60 days after surgery
Secondary	Remission and cancer free survival	Remission and cancer free survival	5 years