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PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction (PRESET)

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ClinicalTrials.gov Identifier: NCT02722785
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Jesper Frank Christensen, PhD, Rigshospitalet, Denmark

Brief Summary:

Background:

For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function, which are strong predictor of post-surgical complication and survival . A strong rationale exists to explore how to develop supportive interventions aimed at maintaining/improving muscle function (lean body mass and muscle strength) during the pre-surgical phase.

This study explores the safety, feasibility and efficacy of structured pre- and post-operative exercise training in patient undergoing surgery for cancer of the gastro-esophageal junction.

Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.

Methods: In a case-control design, patients will be allocated to either an exercise training intervention group, or a usual-care observational group, based on geographical location. Forty patients will be included in this case-control study and allocated by geographical region as follows; 20 training intervention-cases living in the greater Copenhagen area, and 20 observational control subjects living outside the greater Copenhagen area.

All patients will undergo a total of 5 assessments during the perioperative trajectory; twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15 weeks post-surgery, and at 1-year follow-up).

Assessments include measures of body composition by DXA scan and bioelectrical impedance analysis: systemic inflammation in fasting blood sample; quality of life by self-report questionnaires; physical function by handgrip strength and sit-to-stand test.

As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood samples before, during and after an acute exercise bout exercise in order to explore the acute systemic changes in exercise-regulated biomarkers.


Condition or disease Intervention/treatment Phase
Gastro-esophageal Cancer Behavioral: Aerobic and Resistance Exercise Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PeRioperative Study of Exercise Training - a None-randomized Feasibility Study: Usual Care Observation vs Exercise Training Intervention in Patients With Operable Cancer of the Gastroesophageal Junction
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care Observation Group
Patients allocated to usual care control will receive the standard patient care program as provided by the department of surgical gastroenterology, Rigshospitalet
Experimental: Aerobic and Resistance Exercise Training
Patients allocated to this group will receive usual care plus a supervised aerobic and resistance exercise program at CFAS' facilities consisting of 2 weekly sessions of approximately 60 minutes.
Behavioral: Aerobic and Resistance Exercise Training
Supervised aerobic and resistance exercise program consisting of 2 weekly sessions of approximately 60 minutes. Patients will perform a test of maximum cardio-respiratory (Watt-max test) and muscle strength (1 repetition maximum [1-RM] test) capacity. Using the patient's individual capacity score (Watt-max and 1RM), a personalized exercise program will be prescribed. After a light warm-up, patients will perform 20-30 min of aerobic interval training of stationary bicycle. Resistance training comprises 4 exercises for the major muscle groups: chest press, leg press, lateral pull, and knee extension with 3-4 sets of 8 to 15 repetitions. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to 1-year follow-up ]

    Recording of adverse events will be separated into two procedures: recordings during trial visits and recordings during exercise sessions.

    AE/SAE recording during trial assessment visits This procedure will concern any AE/SAE which can be attributed to study-related assessment procedures during the trial visits, i.e. discomfort during physical tests or blood sampling, which will be recorded immediately during the visit and recorded for the given visit. Also, for each trial visit we will collect patients' self-report of AE/SAEs, which may have occurred during the period since the last trial visit without our knowledge.

    AE/SAE recording during exercise sessions For every exercise session, a trained instructor will supervise the exercise program including recording of AE/SAEs during these session


  2. Adherence to prescribed exercise program [ Time Frame: Baseline to 3 months post surgery ]
    Proportion of exercise sessions completed.


Secondary Outcome Measures :
  1. Changes in fat percentage [ Time Frame: Baseline to 1-year follow-up ]
    Body fat percentage is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

  2. Changes in lean mass [ Time Frame: Baseline to 1-year follow-up ]
    Lean mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

  3. Changes in fat mass [ Time Frame: Baseline to 1-year follow-up ]
    Body fat mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

  4. Changes in Plasma Total-Cholesterol concentrations [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

  5. Changes in Plasma LDL-Cholesterol concentrations [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of LDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

  6. Changes in Plasma HDL-Cholesterol concentrations [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of HDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

  7. Changes in Plasma triglyceride concentrations [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of triglyceride will be measured in fasting blood samples by standard laboratory methods.

  8. Changes in HbA1C (fasting blood samples) [ Time Frame: Baseline to 1-year follow-up ]
    HbA1C will be measured in fasting blood samples by standard laboratory methods.

  9. Changes in Tumor Nekrosis Factor alpha (TNFa) concentration [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of TNFa will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

  10. Changes in Interleuken (IL)-6 concentration [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of IL-6 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

  11. Changes in Interleukin (IL)-8 concentration [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of IL-8 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

  12. Changes in Interleukin (IL)-10 concentration [ Time Frame: Baseline to 1-year follow-up ]
    Concentrations of IL-10 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

  13. Changes in patient-reported Quality of Life - FACT [ Time Frame: Baseline to 1-year follow-up ]
    Patient reported quality of life is measured by Functional Assessment of Cancer Treatment (FACT)

  14. Changes in Sleep Quality [ Time Frame: Baseline to 1-year follow-up ]
    Patient reported sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) questionaire

  15. Changes in Anxiety and Depression [ Time Frame: Baseline to 1-year follow-up ]
    Patient reported Anxiety and Depression is measured by the Hospital Anxiety and Depression Scale (HADS).

  16. Changes in Physical Activity level [ Time Frame: Baseline to 1-year follow-up ]
    Patient reported physical activity is measured by the Internations Physical Activity Questionaire (IPAQ) - short form

  17. Changes in physical function [ Time Frame: Baseline to 1-year follow-up ]
    Sit-to-stand test: Lower-body physical function is assessed by 30-second sit-to-stand test. Using a chair fixed to the ground with a seat 45 cm above the ground subjects will be instructed to sit in the middle of the chair, back straight, arms crossed over their chest, feet flat on the floor. Correct technique will be demonstrated first, and subjects will practice for two-three repetitions. On the signal "go" subjects will be asked to stand then return to the seated position, as many times as possible in 30 seconds.

  18. Changes in hand-grip strength [ Time Frame: Baseline to 1-year follow-up ]
    Handgrip strength is assessed by hand-held dynamometer. Grip strength is measured in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score.

  19. Changes in Forced Expiration Volume in 1 second (FEV1) [ Time Frame: Baseline to 1-year follow-up ]
    FEV1 is evaluated by validated assessment measure of pulmonary function. The patient is instructed to make a complete inspiration and then inserts the mouthpiece into the mouth, closes the lips around it but with the jaws apart, and blows out through the mouth as hard and as completely as possible with strong verbal encouragement given throughout this sequence. The FEV1 score is the fraction of the total volume which is expired in the first second


Other Outcome Measures:
  1. Tissue sampling - Optional [ Time Frame: At baseline and at surgery ]
    For the pre-surgical period (at baseline- and during surgery), we will ask for patients' separate consent to do a gastroscopy with sampling of a tumor biopsy; a muscle biopsy from m. vastus lateralis, fat biopsy from subcutaneous abdominal adipose tissue; and a blood sample, all of which will be collected during full anesthesia. A gastroscopy will be performed and endoluminal tumor biopsies will be collected under full anesthesia in patients who have given informed consent, after the diagnostic laparoscopy is completed. Muscle biopsies of approx. 200 mg per biopsy, will be collected from m. vastus lateralis using the Bergstrom-technique, and fat biopsies of approx. 200 mg per biopsy will be collected from the subcutaneous adipose tissue in the abdomen. Standard procedure requires the resection specimen to be dissected and cut open to determine lymph node classification and resection margins.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients diagnosed with histologically verified, resectable adenocarcinoma of the GEJ.

Exclusion Criteria:

  • Deemed in-operable at multidisciplinary medical conference
  • Pregnancy
  • Any other known malignancy requiring active treatment
  • In-eligible to chemotherapy
  • 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): NCT02722785


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Jesper Frank Christensen, PhD
Investigators
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Principal Investigator: Jesper F Christensen, PhD Rigshospitalet, Denmark

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Responsible Party: Jesper Frank Christensen, PhD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02722785     History of Changes
Other Study ID Numbers: PRESET - GEJ Cancer
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jesper Frank Christensen, PhD, Rigshospitalet, Denmark:
Exercise training
Surgical complications
Cancer prognosis
Muscle function
Body composition
Pulmonary function
Quality of life

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases