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PREoperativ Study of Exercise Training (PRESET-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490565
Recruitment Status : Suspended (Due to the CORONA virus outbreak, recruitment of new subjects is suspended as of March 13 2020 and untill further notice.)
First Posted : April 6, 2018
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Lundbeck Foundation
Beckett Foundation
Region Capital Denmark
Information provided by (Responsible Party):
Jesper Frank Christensen, PhD, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
GastroEsophageal Cancer Behavioral: Exercise training Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EX group
Exercise training
Behavioral: 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.

No Intervention: CON-group
Usual Care



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490565


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Jesper Frank Christensen, PhD
Lundbeck Foundation
Beckett Foundation
Region Capital Denmark
Investigators
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Principal Investigator: Jesper F Christensen, PhD Rigshospitalet, Denmark
Study Chair: Lars B Svendsen, DMSc Rigshospitalet, Denmark

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Responsible Party: Jesper Frank Christensen, PhD, Postdoc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03490565    
Other Study ID Numbers: PRESET-RCT
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesper Frank Christensen, PhD, Rigshospitalet, Denmark:
exercise training
treatment tolerability
treatment complications