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

NCT02722785 | Completed

• 1 other identifier: PRESET - GEJ Cancer
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-esophageal Cancer

Keywords

Exercise training; Surgical complications; Cancer prognosis; Muscle function; Body composition; Pulmonary function; Quality of life

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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

  Baseline to 1-year follow-up

• Adherence to prescribed exercise program

  Proportion of exercise sessions completed.

  Baseline to 3 months post surgery

Secondary Outcomes (19)

• Changes in fat percentage

  Baseline to 1-year follow-up

• Changes in lean mass

  Baseline to 1-year follow-up

• Changes in fat mass

  Baseline to 1-year follow-up

• Changes in Plasma Total-Cholesterol concentrations

  Baseline to 1-year follow-up

• Changes in Plasma LDL-Cholesterol concentrations

  Baseline to 1-year follow-up

Other Outcomes (1)

• Tissue sampling - Optional

  At baseline and at surgery

Study Arms (2)

Usual Care Observation Group

NO INTERVENTION

Patients allocated to usual care control will receive the standard patient care program as provided by the department of surgical gastroenterology, Rigshospitalet

Aerobic and Resistance Exercise Training

EXPERIMENTAL

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

Interventions

Aerobic and Resistance Exercise Training BEHAVIORAL

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.

Aerobic and Resistance Exercise Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jesper Frank Christensen, PhD: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Simonsen C, Thorsen-Streit S, Sundberg A, Djurhuus SS, Mortensen CE, Qvortrup C, Pedersen BK, Svendsen LB, de Heer P, Christensen JF. Effects of high-intensity exercise training on physical fitness, quality of life and treatment outcomes after oesophagectomy for cancer of the gastro-oesophageal junction: PRESET pilot study. BJS Open. 2020 Oct;4(5):855-864. doi: 10.1002/bjs5.50337. Epub 2020 Aug 28.

  PMID: 32856785 DERIVED

Study Officials

• Jesper F Christensen, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 30, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)