Postoperative Exercise Training in Patients With Colorectal Liver Metastases Undergoing Surgery (ELMA)

NCT04751773 | Active Not Recruiting

• 1 other identifier: ELMA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery is a primary treatment modality in the intended curative treatment of colorectal liver metastases (CRLM). However, surgery elicits a cascade of potentially detrimental stress responses that may drive the onset of long-term disease progression. Exercise training is emerging as an adjunct treatment in surgical oncology and holds potential to modify the surgical stress response. Against this background, we designed the present randomized controlled trial to evaluate the therapeutic role of pre- and postoperative exercise training in patients with CRLM undergoing open liver resection.

Conditions

Colorectal Liver Metastasis

Keywords

Aerobic exercise; Resistance exercise; Perioperative medicine; Prehabilitation; Rehabilitation; Cancer; Surgical oncology; Surgery; Exercise oncology

Outcome Measures

Primary Outcomes (1)

• Serious adverse events

  From discharge to 8 weeks after discharge

Secondary Outcomes (17)

• Postoperative hospital admissions

  From discharge to 8 weeks after discharge

• Relative dose intensity (RDI) of adjuvant chemotherapy

  From date of planned initiation of adjuvant chemotherapy until 8 weeks after discharge

• Time to initiation of adjuvant chemotherapy

  From surgery until 8 weeks after discharge

• Patient-reported symptomatic adverse events

  Baseline, 7 days after discharge, 7 days after each administration of adjuvant chemotherapy, 8 weeks after discharge.

• Surgical stress: IL-1β

  Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge

Other Outcomes (75)

• 3-years cancer-specific survival

  Randomization to 3 years after randomization

• 3-years overall survival

  Randomization to 3 years after randomization

• Carcinoembryonic antigen (CEA)

  Baseline, postoperative day 15, 8 weeks after discharge

Study Arms (2)

Standard care alone (CON)

NO INTERVENTION

Participants allocated to CON receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. Participants allocated to CON are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program.

Postoperative exercise training and standard care (EX)

EXPERIMENTAL

Participants allocated to EX receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark, and postoperative exercise training. The postoperative exercise training program consists of 8 weeks of supervised and home-based exercise 5 times/week. The intensity and duration are progressively increased during the postoperative period

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

Perioperative exercise training

Postoperative exercise training and standard care (EX)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \<18
• Pregnancy
• Other known malignancy requiring active cancer treatment that prohibits execution of test or training procedures
• Conditions that prohibit execution of trial procedures
• Inability to understand the Danish language.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Thomsen SN, Krabek R, Yfanti C, Sjoberg S, Sundberg A, Dalsgaard DM, Thomsen LM, Aasvang EK, Qvortrup C, Mau-Sorensen M, Pedersen BK, Larsen PN, Sillesen MH, Schultz NA, Christensen JF, Simonsen C. Postoperative Exercise Training in Patients with Colorectal Liver Metastases A Randomized Controlled Trial. Ann Surg. 2024 Nov 11. doi: 10.1097/SLA.0000000000006587. Online ahead of print.

  PMID: 39523954 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jesper F Christensen, PhD

  Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the exercise intervention instructors cannot be blinded, given the nature of the intervention. The outcome assessors of the primary and key secondary outcomes (adverse events and markers of surgical stress, respectively) will be blinded. For practical reasons, the outcome assessors of the following secondary outcomes will be not be blinded: resting cardiovascular factors, aerobic capacity, muscle strength, functional performance, and body composition and anthropometrics.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 12, 2021
• Study Start: March 12, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)