Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colon Cancer Rectal Cancer Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial with an intervention arm and a standard of care arm.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.

Study Groups

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Prehabilitation

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.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type OTHER

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.

Standard of Care

Receives standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No