Does Prehabilitation Improve Outcome in Coloncancer Surgery?

NCT04199208 | Not Yet Recruiting

• 1 other identifier: PRIO01
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgery--Complications

Keywords

exercise therapy; perioperative period; coloncancer

Outcome Measures

Primary Outcomes (2)

• Complications

  Severity of postoperative complications according do Clavien-Dindo

  Assessed when patient is discharged from hospital

• Complications

  Number of complication(s) according to POMS

  Assessed at postoperative day 5.

Secondary Outcomes (3)

• Quality of life with SF-36

  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.

• Disease-free survival

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

• Overall survival

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

Study Arms (2)

Standard Care Arm

ACTIVE COMPARATOR

Standard perioperative care is given.

Other: Standard Care Arm

Interventional Arm

EXPERIMENTAL

Intervention of prehabilitation and immunonutrition is given prior to surgery

Other: Prehabilitation and Immunonutrition

Interventions

Prehabilitation and Immunonutrition OTHER

See study synopsis

Interventional Arm

Standard Care Arm OTHER

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

Standard Care Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Interventions

Preoperative Exercise; Immunonutrition Diet

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stefan Öberg, MD, PhD

  Region Skåne/Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Öberg, MD, PhD

CONTACT

+46424061000; stefan.oberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized two-armed clinical trial

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: October 1, 2020
• Primary Completion: January 7, 2023
• Study Completion (Estimated): January 7, 2028
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share