PREoperativ Study of Exercise Training

N/AActive Not RecruitingNCT03490565

Jesper Frank Christensen, PhD310 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Exercise trainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Risk of treatment failure

The frequency of patients scheduled to receive neo-adjuvant treatment and tumor resection with curative intend, but fail to reach surgery due to death, disease progression or physical deterioration

Time frame: From date of randomization, until the date of treatment failure is clinically determined before scheduled surgery assessed for up to 20 weeks

Secondary Outcomes

Time to disease progression

Time from point of diagnosis to clinical disease relapse

Time frame: Baseline to 3 year follow-up

3 year disease free survival

Frequency of patients alive without clinical disease relapse 3 years after diagnosis

Time frame: Baseline to 3 year follow-up

3 year overall survival

Frequency of patients alive 3 years after diagnosis

Time frame: Baseline to 3 year follow-up

Health Related Quality of Life

Changes from baseline in the Functional Assessment of Cancer Therapy (FACT) questionaire

Time frame: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up

Anxiety and Depression

Changes from baseline in the HADs questionaire

Time frame: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up

Pre-operative risk of hospitalization

Frequency of non-scheduled hospitalization during neoadjuvant treatment

Time frame: From date of randomization, until the date of hospitilization before scheduled surgery assessed for up to 20 weeks

Total length of hospital stays

Total number of days hospitalized

Time frame: From date of randomization up to 30 days after surgery

Tumor regression grade

Pathology assessment of tumor response to neoadjuvant treatment

Time frame: From date of randomization (baseline tumor biopsy) to tumor resection (surgery), up to 20 weeks

Risk of neoadjuvant treatment dose-reduction

Incidence of dose-reduction

Time frame: From date of randomization to the date of surgery, up to 20 weeks

Risk of neoadjuvant treatment complications

Incidence of registered toxicities (graded 1-4)

Time frame: From date of randomization to the date of surgery, up to 20 weeks

Risk of post-operative complications

Incidence of registered post-operative complications (Clavien-Dindo grade 2-4)

Time frame: From surgery to 30 days post surgery

Cardiopulmonary fitness

Changes in VO2peak