GastroEsophageal CancerPRESET-RCTNCT03490565
PREoperativ Study of Exercise Training
A study testing Exercise training in people with GastroEsophageal Cancer, run by Jesper Frank Christensen, PhD at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- GastroEsophageal Cancer
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Aug 2018to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with histologically verified, resectable adenocarcinoma of the esophagus, stomach or gastro-esophageal junction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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
- Being tested
- Exercise training
- Keywords
- exercise training, treatment tolerability, treatment complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EX group | Active comparator | Exercise training Receives: Behavioral: Exercise training |
| CON-group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Time from point of diagnosis to clinical disease relapse
Measured: Baseline to 3 year follow-up
3 year disease free survival
Frequency of patients alive without clinical disease relapse 3 years after diagnosis
Measured: Baseline to 3 year follow-up
3 year overall survival
Frequency of patients alive 3 years after diagnosis
Measured: Baseline to 3 year follow-up
Health Related Quality of Life
Changes from baseline in the Functional Assessment of Cancer Therapy (FACT) questionaire
Measured: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up
Anxiety and Depression
Changes from baseline in the HADs questionaire
Measured: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up
Pre-operative risk of hospitalization
Frequency of non-scheduled hospitalization during neoadjuvant treatment
Measured: From date of randomization, until the date of hospitilization before scheduled surgery assessed for up to 20 weeks
Total length of hospital stays
Total number of days hospitalized
Measured: From date of randomization up to 30 days after surgery
Tumor regression grade
Pathology assessment of tumor response to neoadjuvant treatment
Measured: From date of randomization (baseline tumor biopsy) to tumor resection (surgery), up to 20 weeks
Risk of neoadjuvant treatment dose-reduction
Incidence of dose-reduction
Measured: From date of randomization to the date of surgery, up to 20 weeks
Risk of neoadjuvant treatment complications
Incidence of registered toxicities (graded 1-4)
Measured: From date of randomization to the date of surgery, up to 20 weeks
Risk of post-operative complications
Incidence of registered post-operative complications (Clavien-Dindo grade 2-4)
Measured: From surgery to 30 days post surgery
Cardiopulmonary fitness
Changes in VO2peak
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Maximum muscle strength
Changes in 1 repetition maximum strength leg-press
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Lean Body Mass
Changes in whole-body lean mass assessed by
dual energy x-ray absorptiometry (DXA) scan
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Fat percentage
Changes in whole-body fat percentage assessed by DXA scan
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Appendicular lean mass
Changes in appendicular lean mass assessed by DXA scan
Measured: Baseline to scheduled surgery
Leg-extensor power
Changes in maximum leg power assessed by Nottingham Power Rig
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Blood Volume
Changes in blood volume assessed by CO2 rebreathing
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
TNFa
Changes in plasma TNFa concentration
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Interleukin (IL)-6
Changes in plasma IL-6 concentration
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
CRP
Changes in plasma CRP concentration
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
HbA1c
Changes in plasma HbA1c concentration
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
IL-10
Changes in plasma IL-10 concentration
Measured: From visit 1 (date of randomization, before neoajuvant treatment) until to visit 2 (the week before surgery, after neoadjuvant treatment) up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start16 Aug 2018
- Primary completion31 Jan 2023
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroEsophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesper Frank Christensen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Beckett Foundation, Region Capital Denmark
- Responsible party
- Sponsor-investigator, Jesper Frank Christensen, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper F Christensen, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletLars B Svendsen, DMSc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490565
- Sponsor's protocol ID
- PRESET-RCT
- Acronym
- PRESET-RCT
- Status last verified
- Jun 2023
- First submitted
- 23 Mar 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simonsen C, de Heer P, Thomsen SN, Krabek R, Thorsen-Streit S, Printz Lyngbaek MP, Sundberg A, Hjort ASK, Garbyal RS, Lang Lehrskov L, Kristensen TS, Hillingso JG, Bjerregaard JK, Baeksgaard L, Tolver A, Svendsen LB, Pedersen BK, Qvortrup C, Achiam MP, Christensen JF. Exercise Training During Neoadjuvant Treatment for Gastroesophageal Cancer and Tumor Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2640136. doi: 10.1001/jamanetworkopen.2026.40136.
PubMed 42949746
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03490565
- Acronym / sponsor ID
- PRESET-RCT / PRESET-RCT
- Conditions
- GastroEsophageal Cancer
- Keywords
- exercise training, treatment tolerability, treatment complications
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Jesper Frank Christensen, PhDUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Beckett Foundation, Region Capital Denmark
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EX group | Active comparator | Behavioral: Exercise trainingExercise training |
| CON-group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with histologically verified, resectable adenocarcinoma of the esophagus, stomach or gastro-esophageal junction
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingStructured, 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. | Behavioural | EX group |
Primary outcome
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
23 secondary outcomes
Time to disease progression
Time frame: Baseline to 3 year follow-up
3 year disease free survival
Time frame: Baseline to 3 year follow-up
3 year overall survival
Time frame: Baseline to 3 year follow-up
Health Related Quality of Life
Time frame: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up
Anxiety and Depression
Time frame: Baseline, scheduled surgery, 1-year follow-up, 2-year follow-up, 3-year follow-up
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
Total length of hospital stays
Time frame: From date of randomization up to 30 days after surgery
Tumor regression grade
Time frame: From date of randomization (baseline tumor biopsy) to tumor resection (surgery), up to 20 weeks
Risk of neoadjuvant treatment dose-reduction
Time frame: From date of randomization to the date of surgery, up to 20 weeks
Risk of neoadjuvant treatment complications
Time frame: From date of randomization to the date of surgery, up to 20 weeks
Risk of post-operative complications
Time frame: From surgery to 30 days post surgery
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
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
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
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
Appendicular lean mass
Time frame: Baseline to scheduled surgery
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 42949746Simonsen C, de Heer P, Thomsen SN, Krabek R, Thorsen-Streit S, Printz Lyngbaek MP, Sundberg A, Hjort ASK, Garbyal RS, Lang Lehrskov L, Kristensen TS, Hillingso JG, Bjerregaard JK, Baeksgaard L, Tolver A, Svendsen LB, Pedersen BK, Qvortrup C, Achiam MP, Christensen JF. Exercise Training During Neoadjuvant Treatment for Gastroesophageal Cancer and Tumor Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2640136. doi: 10.1001/jamanetworkopen.2026.40136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper F Christensen, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Lars B Svendsen, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with GastroEsophageal Cancer, run by Jesper Frank Christensen, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.