NCT04167436

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

November 11, 2019

Last Update Submit

March 2, 2022

Conditions

Colon CancerRectal CancerFrailty

Keywords

PrehabilitationColon cancerWHO performance statusRectal cancerExerciseNutritional supplement

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Disease specific quality of life - EORTC c30

    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

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

  • Overall quality of life - SF-36

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

  • Psychological health - Depression - PHQ-9

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

  • Psychological health - General anxiety - GAD-7

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

  • +7 more secondary outcomes

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Receives standard of care

Interventions

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.

Prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zealand University Hospital

Køge, Danmark, 4600, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Danmark, 4200, Denmark

RECRUITING

Related Publications (4)

  • 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.

    PMID: 38060453DERIVED

  • 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.

    PMID: 37162250DERIVED

  • 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.

    PMID: 35588252DERIVED

  • 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.

    PMID: 35063042DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsFrailtyMotor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial with an intervention arm and a standard of care arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 18, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2022

Study Completion

August 1, 2022

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations

DK(2)