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Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Primary Purpose

Colon Cancer, Rectal Cancer, Frailty

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Prehabilitation, Colon cancer, WHO performance status, Rectal cancer, Exercise, Nutritional supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zealand University HospitalRecruiting
  • Slagelse HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation

Standard of Care

Arm Description

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.

Receives standard of care

Outcomes

Primary Outcome Measures

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
Changes in physical fitness prior to surgery
Changes in VO2 max between baseline and prior to surgery
Complications
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
Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)

Secondary Outcome Measures

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
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.
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.
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
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
Physical function (6-MWT)
6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters
Physical function (STS)
Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds.
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.
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.
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.
Nutritional status
Increase/decrease in total body weight in percent.
Remission and cancer free survival
Remission and cancer free survival

Full Information

First Posted
November 11, 2019
Last Updated
March 2, 2022
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04167436
Brief Title
Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients
Official Title
Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Frailty
Keywords
Prehabilitation, Colon cancer, WHO performance status, Rectal cancer, Exercise, Nutritional supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial with an intervention arm and a standard of care arm.
Masking
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.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Receives standard of care
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Recovery 15
Description
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
Time Frame
3 days after surgery
Title
Changes in physical fitness prior to surgery
Description
Changes in VO2 max between baseline and prior to surgery
Time Frame
Baseline, prior to surgery and 30 days after surgery
Title
Complications
Description
Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.
Time Frame
30 days after surgery
Title
Changes in immunological function
Description
Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)
Time Frame
Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen
Secondary Outcome Measure Information:
Title
Disease specific quality of life - EORTC c30
Description
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
Time Frame
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Title
Disease specfic quality of life - EORTC c29
Description
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.
Time Frame
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Title
Overall quality of life - SF-36
Description
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.
Time Frame
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Title
Psychological health - Depression - PHQ-9
Description
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
Time Frame
the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery
Title
Psychological health - General anxiety - GAD-7
Description
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
Time Frame
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Title
Physical function (6-MWT)
Description
6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Title
Physical function (STS)
Description
Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds.
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery.
Title
Physical function (Stair climb test)
Description
Stair climb test will be measured as the number of steps (17 mc in height) the paitent can rise in 30 secounds.
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Title
Physical function (Leg extension test)
Description
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.
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Title
Physical function (Hand grip strength)
Description
Hand grip strength measured by hand-held dynanometer in kilograms. Measured 3 times on each hand and will use the maximum obtained.
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Title
Nutritional status
Description
Increase/decrease in total body weight in percent.
Time Frame
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Title
Remission and cancer free survival
Description
Remission and cancer free survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zealand University Hospital
City
Køge
State/Province
Danmark
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus D Bojesen, MD
Phone
26193789
Email
rasmus.bojesen@gmail.com
Facility Name
Slagelse Hospital
City
Slagelse
State/Province
Danmark
ZIP/Postal Code
4200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus D Bojesen, MD
Phone
26193789
Email
rasmus.bojesen@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35588252
Citation
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.
Results Reference
derived
PubMed Identifier
35063042
Citation
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.
Results Reference
derived

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Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

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