Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

March 2, 2022 updated by: Zealand University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Køge, Danmark, Denmark, 4600
        • Recruiting
        • Zealand University Hospital
        • Contact:
      • Slagelse, Danmark, Denmark, 4200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Recovery 15
Time Frame: 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
3 days after surgery
Changes in physical fitness prior to surgery
Time Frame: Baseline, prior to surgery and 30 days after surgery
Changes in VO2 max between baseline and prior to surgery
Baseline, prior to surgery and 30 days after surgery
Complications
Time Frame: 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.
30 days after surgery
Changes in immunological function
Time Frame: 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)
Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease specific quality of life - EORTC c30
Time Frame: 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
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
Time Frame: 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.
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Overall quality of life - SF-36
Time Frame: 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.
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Psychological health - Depression - PHQ-9
Time Frame: 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
the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery
Psychological health - General anxiety - GAD-7
Time Frame: 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
the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Physical function (6-MWT)
Time Frame: 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
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (STS)
Time Frame: 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.
The day prior to surgery, 30 days after surgery, and 60 days after surgery.
Physical function (Stair climb test)
Time Frame: 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.
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (Leg extension test)
Time Frame: 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.
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (Hand grip strength)
Time Frame: 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.
The day prior to surgery, 30 days after surgery, and 60 days after surgery
Nutritional status
Time Frame: The day prior to surgery, 30 days after surgery, and 60 days after surgery
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
Time Frame: 5 years
Remission and cancer free survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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