PREoperativ Study of Exercise Training

NCT ID: NCT03490565

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

GastroEsophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EX group

Exercise training

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

Structured, supervised, high-intensity combined aerobic and resistance exercise. Based on patients' individual capacity (Wattmax and 1RM), a personalized exercise program will be prescribed. Following a 5 minutes warm up, the patients will perform 21 min of aerobic interval training on a stationary bicycle consisting of three 4 minute high intensity intervals (85-95% HRmax) with 3 minutes of active pause between each interval. The resistance training comprises 4 functional exercises by performed using bodyweight, elastic resistance bands or kettlebells followed by resistance exercises in machines for the major muscle groups: chest press, leg press, seated rows, and leg extension with 1 warm-up set followed by 3-4 sets of 8 to 12 repetitions.

CON-group

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

Structured, supervised, high-intensity combined aerobic and resistance exercise. Based on patients' individual capacity (Wattmax and 1RM), a personalized exercise program will be prescribed. Following a 5 minutes warm up, the patients will perform 21 min of aerobic interval training on a stationary bicycle consisting of three 4 minute high intensity intervals (85-95% HRmax) with 3 minutes of active pause between each interval. The resistance training comprises 4 functional exercises by performed using bodyweight, elastic resistance bands or kettlebells followed by resistance exercises in machines for the major muscle groups: chest press, leg press, seated rows, and leg extension with 1 warm-up set followed by 3-4 sets of 8 to 12 repetitions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients with histologically verified, resectable adenocarcinoma of the esophagus, stomach or gastro-esophageal junction

Exclusion Criteria

• Deemed inoperable at the point of diagnoses
• Pregnancy
• Any other known malignancy requiring active treatment
• Not eligible for preoperative chemo- or chemoradiotherapy
• Performance status > 1
• Physical disabilities precluding physical testing and/or exercise
• Inability to read and understand Danish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Beckett Foundation

OTHER

Sponsor Role: collaborator

Region Capital Denmark

OTHER

Sponsor Role: collaborator

Jesper Frank Christensen, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jesper Frank Christensen, PhD

Postdoc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jesper F Christensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Lars B Svendsen, DMSc

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

PRESET-RCT

Identifier Type: -

Identifier Source: org_study_id