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Gastro-esophageal CancerNCT05650827

Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

A study testing Resistance training and Protein supplement in people with Gastro-esophageal Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastro-esophageal Cancer
What is being tested?
Resistance training and Protein supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteDenmark
Study dates
24 Feb 2023to 31 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction
  • referred to first line chemotherapy.

Who cannot join

  • Age < 18
  • Living outside the greater Copenhagen area
  • Any other malignancy requiring active treatment
  • Not eligible for chemotherapy
  • Performance status > 2
  • Not able to swallow liquids
Show all 10Show fewer
  • Parenteral nutrition or enteral nutrition via feeding tube
  • Physical or mental disabilities that prohibit execution of test or training procedures
  • Pregnancy
  • Inability to understand the Danish language

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death.

Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy.

A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.

Being tested
Resistance training, Protein supplement
Keywords
Exercise oncology, Resistance exercise, Cancer, Cancer cachexia, Protein supplements, Sarcopenia, Palliative chemotherapy
Medical subject headings
Neoplasms, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance trainingBehavioural

    10 weeks of resistance training 3 times pr. week.

  • Protein supplementDietary supplement

    A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight

Study groups in NCT05650827
Study groupRoleWhat they receive
Standard Care ControlNo interventionParticipants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.
Exercise and protein supplements intervention groupExperimentalParticipants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. The intervention consists of resistance training and a daily protein supplement.
Receives: Behavioral: Resistance training; Dietary Supplement: Protein supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise feasibility: Exercise sessions attendance

    The number of attended exercise training sessions relative to the number of planed exercise sessions

    Measured: From baseline until end of intervention (10 weeks)

  2. Exercise feasibility: Relative dose-intensity of protein supplement

    The actual amount consumed relative to the amount prescribed over the intervention period

    Measured: From baseline until end of intervention (10 weeks)

  3. Incidence of Serious Adverse Events (SAEs).

    SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.

    Measured: Baseline until end of intervention (10 weeks)

Secondary outcomes (53)
  1. Exercise feasibility: Relative dose intensity of exercise

    The actual dose relative to the prescribed minimum dose

    Measured: Baseline until end of intervention (10 weeks)

  2. Exercise feasibility: Early termination of exercise sessions

    Termination of an exercise session before the prescribed exercises have been performed

    Measured: Baseline until end of intervention (10 weeks)

  3. Exercise feasibility: Exercise intervention interruptions

    Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session

    Measured: Baseline until end of intervention (10 weeks)

  4. Exercise feasibility: Permanent discontinuation

    Incidence of permanent withdrawal from the intervention before intervention period has ended.

    Measured: Baseline until end of intervention (10 weeks)

  5. Body composition and anthropometrics: Total lean mass

    Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)

    Measured: Baseline, end of week 10

  6. Body composition and anthropometrics: Appendicular lean mass

    Changes in appendicular lean mass, assessed by DXA

    Measured: Baseline, end of week 10

  7. Body composition and anthropometrics: Total fat mass

    Changes in total fat mass, assessed by DXA

    Measured: Baseline, end of week 10

  8. Body composition and anthropometrics: Fat percentage

    Changes in fat percentage, assessed by DXA

    Measured: Baseline, end of week 10

  9. Body composition and anthropometrics: Bone mineral density

    Changes in bone mineral density, assessed by DXA

    Measured: Baseline, end of week 10

  10. Body composition and anthropometrics: Muscle thickness

    Changes in thickness of the vastus lateralis, assessed by ultrasound

    Measured: Baseline, end of week 10

  11. Body composition and anthropometrics: Skeletal muscle index

    Changes in skeletal muscle index, assessed by diagnostic CT scans

    Measured: At diagnose, after 10 weeks intervention and at 1 year follow up

  12. Body composition and anthropometrics: Skeletal muscle attenuation

    Changes in skeletal muscle attenuation, assessed by diagnostic CT scans

    Measured: At diagnose, end of week 10

  13. Body composition and anthropometrics: Adipose tissue index

    Changes in adipose tissue index, assessed by diagnostic CT scans

    Measured: At diagnose, end of week 10

  14. Body composition and anthropometrics: Body mass

    Changes in body mass

    Measured: Baseline, end of week 10

  15. Body composition and anthropometrics: Body mass index

    Changes in body mass index

    Measured: Baseline, end of week 10

  16. Body composition and anthropometrics: Hip circumference

    Changes in hip circumference

    Measured: Baseline, end of week 10

  17. Body composition and anthropometrics: Waist circumference

    Changes in waist circumference

    Measured: Baseline, end of week 10

  18. Muscle strength: Leg press maximal muscle strenght

    Changes in leg press one repetition maximum (1RM)

    Measured: Baseline, end of week 10

  19. Muscle strength: Chest press maximal muscle strenght

    Changes in chest press 1RM

    Measured: Baseline, end of week 10

  20. Muscle strength: Hand grip strenght

    Changes in hand grip strength, assessed using a dynamometer

    Measured: Baseline, end of week 10

  21. Functional performance: Habituel gait speed

    Changes in habitual gait speed

    Measured: Baseline, end of week 10

  22. Functional performance: Maximal gait speed

    Changes in maximal gait speed

    Measured: Baseline, end of week 10

  23. Functional performance: Sit-to-stand

    Changes in sit-to-stand power.

    Measured: Baseline, end of week 10

  24. Functional performance: Stair climb

    Changes in stair climbing power

    Measured: Baseline, end of week 10

  25. Resting metabolic rate

    Changes in resting metabolic rate

    Measured: Baseline, end of week 10

  26. Blood pressure: Systolic blood pressure

    Changes in systolic blood pressure

    Measured: Baseline, end of week 10

  27. Blood pressure: Diastolic blood pressure

    Changes in diastolic blood pressure

    Measured: Baseline, end of week 10

  28. Heart rate

    Changes in resting heart rate

    Measured: Baseline, end of week 10

  29. 1 and 2-years cancer-specific survival

    Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization

    Measured: Randomization to 1 and 2 years after randomization

  30. 1 and 2-years over-all survival

    Proportion of patients who have not died 1 and 2 years after randomization

    Measured: Randomization to 1 and 2 years after randomization

  31. Progression-free survival

    Time to progression

    Measured: Randomization to 2 years after randomization

  32. Treatment tolerance: Hospitalization

    Unscheduled hospitalization

    Measured: 3, 6 and 9 weeks after randomization

  33. Treatment tolerance: Relative dose intensity

    Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)

    Measured: 3, 6 and 9 weeks after randomization

  34. Treatment tolerance: Number of series recieved

    Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)

    Measured: 3, 6 and 9 weeks after randomization

  35. Treatment tolerance: Tolerated dose

    Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)

    Measured: 3, 6 and 9 weeks after randomization

  36. Treatment tolerance: Permanent discontinuation of the treatment

    Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)

    Measured: 3, 6 and 9 weeks after randomization

  37. Treatment effect: Response to chemotherapy

    Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)

    Measured: Randomization to 2 years after randomization

  38. Health-related quality of life: Physical well-being

    Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) (scale-scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  39. Health-related quality of life: Social well-being

    Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  40. Health-related quality of life: Emotional well-being

    Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  41. Health-related quality of life: Functional well-being

    Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

    Measured: Baseline,10 weeks-, 1 year-, 2 years after randomization

  42. Health-related quality of life: gastroesophageal cancer specific

    Changes in patient-reported gastroesophageal cancer specific well-being assessed using FACT-E (scale-scoring 0-68, the higher the score the better quality of life)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  43. Health-related quality of life: cancer cachexia specific

    Changes in patient-reported cancer cachexia specific well-being assessed using Functional Assessment of Cancer Therapy - Cancer Cachexia (scale-scoring 0-48, the higher the score the better quality of life)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  44. Depression

    Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  45. Anxiety

    Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)

    Measured: Baseline, 10 weeks-, 1 year-, and 2 years after randomization

  46. Self-reported physical activity: Walking

    Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, end of week 10

  47. Self-reported physical activity: Moderate intensity physical activity (PA)

    Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ

    Measured: Baseline, end of week 10

  48. Self-reported physical activity: Vigorous intensity PA

    Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ

    Measured: Baseline, end of week 10

  49. Self-reported physical activity: Total PA

    Changes in patient-reported weekly duration of total PA, assessed using the IPAQ (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)

    Measured: Baseline, end of week 10

  50. Self-reported physical activity: Sitting time

    Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ

    Measured: Baseline, end of week 10

  51. Self-reported screening of sarcopenia

    Changes in patient-reported signs of sarcopenia, assessed using The Strength, assistance in walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire (scale scoring: 0-10, the higher the score the better the condition)

    Measured: Baseline, end of week 10

  52. Self-reported three-days dietary records

    Changes in patient-reported three-day record of dietary intake assessed using questionnaries.

    Measured: Baseline, week 5 and week 10

  53. Patient-reported symptomatic adverse events

    Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Measured: One week after each serie of chemotherapy during the intervention (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start24 Feb 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2027 (estimated)

Resources

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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650827
Sponsor's protocol ID
18.10.22
Status last verified
May 2025
First submitted
2 Dec 2022
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krabek R, Kristensen KB, Thomsen SN, Sorensen AH, Christensen PL, Pedersen KC, Rytter A, Dieli-Conwright CM, Suetta C, Sylow L, Pedersen BK, Mau-Sorensen M, Simonsen C. Resistance training and protein supplementation in patients with incurable gastroesophageal cancer: a randomized feasibility trial. Support Care Cancer. 2026 Nov 5;34(11):1194. doi: 10.1007/s00520-026-11430-2.

    PubMed 42982936

Questions about this trial

What is this clinical trial studying?

A study testing Resistance training and Protein supplement in people with Gastro-esophageal Cancer, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 10 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 14 May 2025. 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?

Exercise feasibility: Exercise sessions attendance (time frame: From baseline until end of intervention (10 weeks)). The study lists 3 primary outcomes in all. 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 NCT05650827, 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 14 May 2025.

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