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Colon CancerPhase 2/3NCT04167436

Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

A Phase 2/3 study testing Prehabilitation in people with Colon Cancer and Rectal Cancer, run by Zealand University Hospital at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer, Rectal Cancer, Frailty
What is being tested?
Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesDenmark
Study dates
1 May 2019to 1 Aug 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Undergoing elective colorectal cancer surgery
  • WHO performance status I and II
  • Signed consent

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites, 2 recruiting

  • Zealand University Hospital

    Køge, Danmark, 4600

    Rasmus D Bojesen, MD, 26193789, rasmus.bojesen@gmail.com

    Recruiting

  • Slagelse Hospital

    Slagelse, Danmark, 4200

    Rasmus D Bojesen, MD, 26193789, rasmus.bojesen@gmail.com

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Prehabilitation
Keywords
Prehabilitation, Colon cancer, WHO performance status, Rectal cancer, Exercise, Nutritional supplement
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrehabilitationOther

    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.

Study groups in NCT04167436
Study groupRoleWhat they receive
PrehabilitationExperimentalPatients 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: Other: Prehabilitation
Standard of CareNo interventionReceives standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 days after surgery

  2. Changes in physical fitness prior to surgery

    Changes in VO2 max between baseline and prior to surgery

    Measured: Baseline, prior to surgery and 30 days after surgery

  3. Complications

    Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.

    Measured: 30 days after surgery

  4. Changes in immunological function

    Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)

    Measured: Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen

Secondary outcomes (12)

  1. 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

    Measured: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

  2. 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.

    Measured: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

  3. 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.

    Measured: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

  4. 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

    Measured: the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery

  5. 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

    Measured: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

  6. Physical function (6-MWT)

    6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery

  7. Physical function (STS)

    Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds.

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery.

  8. 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.

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery

  9. 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.

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery

  10. 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.

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery

  11. Nutritional status

    Increase/decrease in total body weight in percent.

    Measured: The day prior to surgery, 30 days after surgery, and 60 days after surgery

  12. Remission and cancer free survival

    Remission and cancer free survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start1 May 2019
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial with an intervention arm and a standard of care arm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167436
Sponsor's protocol ID
REG-040-2017
Status last verified
Feb 2022
First submitted
11 Nov 2019
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bojesen RD, Dalton SO, Skou ST, Jorgensen LB, Walker LR, Eriksen JR, Grube C, Justesen TF, Johansen C, Slooter G, Carli F, Gogenur I. Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial. BJS Open. 2023 Nov 1;7(6):zrad134. doi: 10.1093/bjsopen/zrad134.

    PubMed 38060453

  • 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. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

    PubMed 37162250

  • 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.

    PubMed 35588252

  • 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.

    PubMed 35063042

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prehabilitation in people with Colon Cancer and Rectal Cancer, run by Zealand University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery 15 (time frame: 3 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167436, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.

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