PREoperativ Study of Exercise Training

NCT03490565 | Active Not Recruiting

• 1 other identifier: PRESET-RCT
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Keywords

exercise training; treatment tolerability; treatment complications

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (23)

• Time to disease progression

  Baseline to 3 year follow-up

• 3 year disease free survival

  Baseline to 3 year follow-up

• 3 year overall survival

  Baseline to 3 year follow-up

• Health Related Quality of Life

  Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up

• Anxiety and Depression

  Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up

Study Arms (2)

EX group

ACTIVE COMPARATOR

Exercise training

Behavioral: Exercise training

CON-group

NO INTERVENTION

Usual Care

Interventions

Exercise training 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.

EX group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jesper Frank Christensen, PhD: lead
• Lundbeck Foundation: collaborator
• Beckett Foundation: collaborator
• Region Capital Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jesper F Christensen, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Lars B Svendsen, DMSc

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 6, 2018
• Study Start: August 16, 2018
• Primary Completion: January 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)