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Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Z

Zealand University Hospital

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Colon Cancer
Frailty
Rectal Cancer

Treatments

Other: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04167436
REG-040-2017

Details and patient eligibility

About

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

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Prehabilitation
Experimental group
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.
Treatment:
Other: Prehabilitation
Standard of Care
No Intervention group
Description:
Receives standard of care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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