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NCT Number: NCT04199208

Does Prehabilitation Improve Outcome in Coloncancer Surgery?

The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.

The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 years of older
  • Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)
  • Ventilatory Anaerobic Threshold <11mg/ml/kg
  • Planned open or laparoscopic colectomy due to colon cancer

Exclusion criteria

  • Lower extremity amputee
  • Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease
  • Distal metastases (Locoregional lymph nodes are OK)

Treatment and study plan

Prehabilitation and Immunonutrition

Other

See study synopsis

Standard Care Arm

Other

Standard care as per the daily routines of the Hospital at which the study takes place

Primary outcomes

  1. Complications

    Time frame: Assessed when patient is discharged from hospital

    Severity of postoperative complications according do Clavien-Dindo

  2. Complications

    Time frame: Assessed at postoperative day 5.

    Number of complication(s) according to POMS

Secondary outcomes

  1. Quality of life with SF-36

    Time frame: At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.

    Quality of life

  2. Disease-free survival

    Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.

    Cancer-free survival Cancer-free survival of the group of the group

  3. Overall survival

    Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.

    Overall survival of the group (taking all causes of death into account)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Öberg, MD, PhD

CONTACT

[email protected]

+46424061000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study

Acronym: PRIO

Important dates

Study start
2020
Primary completion
2023
Study completion
2028
First posted
Dec 13, 2019
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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