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NCT Number: NCT03490565

PREoperativ Study of Exercise Training

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

GastroEsophageal Cancer

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Risk of treatment failure

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

    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

Secondary outcomes

  1. Time to disease progression

    Time frame: Baseline to 3 year follow-up

    Time from point of diagnosis to clinical disease relapse

  2. 3 year disease free survival

    Time frame: Baseline to 3 year follow-up

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

  3. 3 year overall survival

    Time frame: Baseline to 3 year follow-up

    Frequency of patients alive 3 years after diagnosis

  4. Health Related Quality of Life

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

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

  5. Anxiety and Depression

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

    Changes from baseline in the HADs questionaire

  6. Pre-operative risk of hospitalization

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

    Frequency of non-scheduled hospitalization during neoadjuvant treatment

  7. Total length of hospital stays

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

    Total number of days hospitalized

  8. Tumor regression grade

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

    Pathology assessment of tumor response to neoadjuvant treatment

  9. Risk of neoadjuvant treatment dose-reduction

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

    Incidence of dose-reduction

  10. Risk of neoadjuvant treatment complications

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

    Incidence of registered toxicities (graded 1-4)

  11. Risk of post-operative complications

    Time frame: From surgery to 30 days post surgery

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

  12. Cardiopulmonary fitness

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in VO2peak

  13. Maximum muscle strength

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in 1 repetition maximum strength leg-press

  14. Lean Body Mass

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in whole-body lean mass assessed by

    dual energy x-ray absorptiometry (DXA) scan

  15. Fat percentage

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in whole-body fat percentage assessed by DXA scan

  16. Appendicular lean mass

    Time frame: Baseline to scheduled surgery

    Changes in appendicular lean mass assessed by DXA scan

  17. Leg-extensor power

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in maximum leg power assessed by Nottingham Power Rig

  18. Blood Volume

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in blood volume assessed by CO2 rebreathing

  19. TNFa

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in plasma TNFa concentration

  20. Interleukin (IL)-6

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in plasma IL-6 concentration

  21. CRP

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in plasma CRP concentration

  22. HbA1c

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in plasma HbA1c concentration

  23. IL-10

    Time frame: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks

    Changes in plasma IL-10 concentration

Sponsors and collaborators

Lead sponsor

Jesper Frank Christensen, PhD

Other

Collaborators

  • Beckett Foundation
  • Lundbeck Foundation
  • Region Capital Denmark

Registry information

Official study title

PREoperativ Study of Exercise Training-RCT: A Phase 3 Randomized Controlled Trial of Preoperative Exercise Training vs Usual Care During Neoadjuvant Treatment in Patients With Gastroesophageal Cancer

Acronym: PRESET-RCT

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Apr 6, 2018
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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