Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

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

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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