Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Other: Prehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Køge, Danmark, Denmark, 4600
      • Recruiting
      • Zealand University Hospital
      • Contact: Rasmus D Bojesen, MD; Phone Number: 26193789; Email: rasmus.bojesen@gmail.com
    • Slagelse, Danmark, Denmark, 4200
      • Recruiting
      • Slagelse Hospital
      • Contact: Rasmus D Bojesen, MD; Phone Number: 26193789; Email: rasmus.bojesen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: Standard of Care; Receives standard of care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Publications and helpful links

General Publications

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
• Bojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Rectal cancer; Prehabilitation; Colon cancer; Nutritional supplement; WHO performance status
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Frailty; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: REG-040-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No