NCT03490565: PRESET-RCT

PREoperativ Study of Exercise Training

Active, enrolled NA Last updated 22 June 2023

What this trial tests

NA trial testing Exercise training in GastroEsophageal Cancer in 310 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 August 2018

Primary endpoint
31 January 2023

31 December 2028

Quick facts

Lead sponsor	Jesper Frank Christensen, PhD
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	310
Start date	16 August 2018
Primary completion	31 January 2023
Estimated completion	31 December 2028
Sites	1 location across Denmark

Drugs / interventions tested

• Exercise training

Conditions studied

• GastroEsophageal Cancer — all drugs for GastroEsophageal Cancer →

Sponsor

Jesper Frank Christensen, PhD

Who can join

Adults 18 to 85, any sex, with GastroEsophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background Patients undergoing resection for gastro-esophageal (GE)-cancer are subjected to high burden of disease and treatment-specific morbidities with potential detrimental impact on survival and quality of life. Exercise training is a promising strategy to improve physical functional before and after tumor resection, but it is not established if this translates into lower risk of peri- and post-operative complications, improved treatment tolerance.

Objectives:

* To explore the effect a preoperative exercise-training intervention on the risk of treatment failure, defined as the risk of not reaching surgery, in patients diagnosed with operable GE cancer.
* To explore the effect of preoperative exercise training on median time to tumor progression (disease free survival), and overall survival
* To explore the effect of preoperative exercise training on the risk of treatment complications
* To explore the effect of preoperative exercise training on health related quality of life, anxiety and depression,cardiopulmonary fitness, muscle strength, and body composition

Subjects and Methods In total, 310 GE-cancer patients will be included in the study and randomly allocated to pre-operative exercise training (n=155) or usual care control (n=155). All participants will undergo 2 study visits; assessed for cardiopulmonary fitness; muscle strength, body composition; blood sample (50 ml); quality of life by questionnaires; physical function; and blood volume profile.

Quality of life will be assessed by questionnaires by self-report three times (at 12, 24, and 36 months after diagnosis), and we will collect data from medical records regarding mortality and disease recurrence up to 36 months after diagnosis.

Treatment arms:

The intervention-group will be prescribed 2-3 weekly supervised exercise training for a total of 12 weeks before surgery during neo-adjuvant chemotherapy. The control group will follow current usual care guidelines. After surgery during adjuvant chemotherapy, both groups will be referred to municipality-based rehabilitation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.