PREoperativ Study of Exercise Training (PRESET-RCT)

Jesper Frank Christensen, PhD

Status: Active, not recruiting

Conditions: GastroEsophageal Cancer

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03490565

PRESET-RCT

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 2 patient groups

EX group

Active Comparator group

Description:

Exercise training

Treatment:

Behavioral: Exercise training

CON-group

No Intervention group

Description:

Usual Care