An interventional study of Multimodal and exercise-based intervention in Pancreas Cancer, Biliary Tract Cancer and Non Small Cell Lung Cancer, sponsored by Herlev and Gentofte Hospital. Completed at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Supportive care
Among 75 studies in Pancreatic Neoplasms with a site in Denmark — 18 open to participants now, 25 under way, 3 of them phase 3. Pancreatic Neoplasms · Denmark.
Among the 75 studies in Pancreatic Neoplasms with a site in Denmark, this one is the 23rd largest by enrollment of the 50 interventional ones that give a count, is one of 3 that started in 2018, is one of 15 with no phase, and was the 34th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →18 of the 75 studies in Pancreatic Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
Incyte Corporation · Sites in Denmark, United States, Australia and 19 more countries
Orion Corporation, Orion Pharma · Sites in Denmark, United States, Finland and 4 more countries
Herlev Hospital · Sites in Denmark
Bayer · Sites in Denmark, United States, Australia and 8 more countries
Inna Chen, MD · Sites in Denmark
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 25 · Phase 3 8
First in 1999; this study’s year is marked. 3 started in 2018.
This study's enrollment of 99 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 88 across the 50 interventional studies, 200 across the 25 observational. Of the 40 that completed or were terminated, 6 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 75 have an industry lead sponsor. The 10 most frequent:
Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
Herlev and Gentofte Hospital has 1 study filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Pancreatic Neoplasms with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02912949Partner Therapeutics, Inc.A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) | 2026-12-31 |
| NCT06145074Zealand University HospitalExamining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC. | 2026-12-31 |
| NCT07629609Barbara Malene FischerBEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer | 2027-01 |
| NCT04611867Inna Chen, MDStudy of PRO in Patients With Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay) | 2027-08-01 |
Among the 75 studies in Pancreatic Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the effect of a multimodal and exercise-based intervention among older patients with advanced pancreatic cancer, biliary tract cancer, or lung cancer during treatment with first-line palliative chemotherapy, immunotherapy or targeted therapy.
The hypotheses: That the multimodal intervention will increase or maintain physical function levels and strength, reduce symptoms and side-effects, improve quality of life, reduce treatment-related complications and hospital admissions, and reduce risk of cancer cachexia and sarcopenia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria, patients with:
In patients with bone :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.
Behavioral: Multimodal and exercise-based intervention
Participants in the control group will receive usual care.
The multimodal and exercise-based intervention is comprised of: 1. Supervised and group-based exercise two times a week (60 minutes per session). The program consists of warm-up, exercises for balance and flexibility, progressive resistance training, and stretching and relaxation. 2. Individualized activity program based on step counts (with activity tracker). Based on each participant's starting point, preferences and motivation, an individualized program will be composed. Evaluation and goal-setting will be conducted once weekly. 3. Nurse-led supportive and motivational counseling; each participant will be invited to two sessions of counseling (in week 1 + 6). Each session will be based on a holistic assessment of each participant's life situation. Advice and counseling will be provided based on identified problems and needs. 4. A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session.
Lower body strength measured with the 30-second chair stand test
Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assessments will be conducted by a blinded physiotherapist
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Recruitment rate
Number of participants included from eligible patients
Time frame: Up to 2 years
Adherence to exercise sessions
Number of exercise sessions attended out of planned sessions
Time frame: Up to 12 weeks
Adherence to counseling sessions
Number of counseling sessions attended out of planned sessions
Time frame: Up to 12 weeks
Adverse events
Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.
Time frame: Up to 12 weeks
Physical performance measured with the 6-minute-walk-test
The distance (measured in meters) a participant is able to walk over a total of six minutes on a hard flat surface. The assessments will be conducted by a blinded physiotherapist
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical performance measured with the 6-meter Gait Speed Test
The assessments will be conducted by a blinded physiotherapist
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Upper-body strength measured with the Handgrip Strength Test
Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical activity level
Step Counts (measured with Garmin Vivofit 3 activity tracker).
Time frame: Change measures (baseline, and 12 weeks).
Qualitative assessment of participants' experiences
Qualitative individual semi-structured interviews with participants from the intervention group
Time frame: After 12 weeks
Quality of life
Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of depression
Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of anxiety
Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptom burden
Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4
Data will be collected from medical charts
Time frame: Up to 6 months
Body weight
Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Body mass index
Reported in kg/m\^2
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Whole-body Lean body mass (LBM)
Measured with Bioimpedance and DXA scans
Time frame: Change measures (baseline, and 12 weeks)
Whole-body fat mass
Measured with Bioimpedance and DXA scans
Time frame: Change measures (baseline, and 12 weeks)
Whole-body bone mineral density
Measured with DXA scans
Time frame: Change measures (baseline, and 12 weeks)
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
Data will be collected from medical charts
Time frame: Up to 6 months
Number of hospital admissions
Data will be collected from medical charts
Time frame: Up to 6 months
Causes of hospitalizations
Data will be collected from medical charts
Time frame: Up to 6 months
Length of hospitalizations (days)
Data will be collected from medical charts
Time frame: Up to 6 months
Survival
Data will be collected from medical charts
Time frame: Up to 2 years
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Jul 2020, 26 months.
Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's 26 months is below that.
Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Herlev and Gentofte Hospital