NCT04880772

Brief Summary

To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 27, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

April 27, 2021

Last Update Submit

September 5, 2023

Conditions

Cancer of ColonCancer of RectumLiver Metastases

Keywords

prehabilitationsurgerycardiopulmonary exercise testingcytokines

Outcome Measures

Primary Outcomes (2)

  • Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min

    Cardiopulmonary exercise Test (CPET) variables

    change in baseline AT & VO2 peak at 4 weeks

  • Inflammatory cytokines

    IL6 IL10 in muscle and blood measured in pg/ml

    change in baseline cytokines at 4 weeks

Secondary Outcomes (5)

  • Clavien-Dindo complication rates

    Up to 30 days from the day of operation

  • Length of hospital stay measured in days

    30 & 90-day mortality

  • Quality of life measures (Illness Perception Questionnaire)

    baseline and within 24 weeks after surgery

  • Hand Grip Strength measured in kg

    baseline, immediately after the intervention, within 24 weeks after surgery

  • Quality of life measure (Mental Adjustment to Cancer Scale)

    baseline and within 24 weeks after surgery

Study Arms (2)

Standard care

NO INTERVENTION

Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia)

Prehabilitation

EXPERIMENTAL

Surgery School plus Moderate intensity exercise \& Forceval (multivitamin)

Other: Prehabilitation

Interventions

PrehabilitationOTHER

exercise \& multivitamin (nutritional/dietary advice)

Prehabilitation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-85
  • Sex: male/female
  • Radiological/tissue cancer diagnosis
  • Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments
  • elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting)
  • Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise

You may not qualify if:

  • Palliative disease
  • Haematological malignancy
  • Pregnancy
  • Emergency surgery
  • Physically unable to undergo CPET
  • Part of any other trial with similar interventions unless previously agreed on with all CIs
  • synchronous disease (operation on HPB \& colorectal cancers at the same operation)
  • No access to digital technology(smart phone, tablet, laptop or home computer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Blackburn Hospital

Blackburn, BB@ 3HH, United Kingdom

Location

Related Publications (1)

  • Lambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527.

    PMID: 33201129BACKGROUND

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joel Lambert

    Senior Clinical Research Fellow

    PRINCIPAL INVESTIGATOR

  • Chris Gaffney

    Lancaster University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
CPET clinician/physiologist will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomisation to standard care or prehabilitation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 11, 2021

Study Start

July 15, 2021

Primary Completion

July 13, 2023

Study Completion

July 13, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Anonymised CPET data to be shared with other researchers. Anonymised tissue and blood samples to be shared with other researchers for analysis

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months
Access Criteria
Full anonymisation

Locations

GB(1)