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Active, Not Recruiting

NCT Number: NCT05650827

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastro-Esophageal Cancer Atrophy Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Resistance training

Behavioral

10 weeks of resistance training 3 times pr. week.

Protein Supplement

Dietary Supplement

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

Primary outcomes

  1. Exercise feasibility: Exercise sessions attendance

    Time frame: From baseline until end of intervention (10 weeks)

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

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

    Time frame: From baseline until end of intervention (10 weeks)

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

  3. Incidence of Serious Adverse Events (SAEs).

    Time frame: Baseline until end of intervention (10 weeks)

    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.

Secondary outcomes

  1. Exercise feasibility: Relative dose intensity of exercise

    Time frame: Baseline until end of intervention (10 weeks)

    The actual dose relative to the prescribed minimum dose

  2. Exercise feasibility: Early termination of exercise sessions

    Time frame: Baseline until end of intervention (10 weeks)

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

  3. Exercise feasibility: Exercise intervention interruptions

    Time frame: Baseline until end of intervention (10 weeks)

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

  4. Exercise feasibility: Permanent discontinuation

    Time frame: Baseline until end of intervention (10 weeks)

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

  5. Body composition and anthropometrics: Total lean mass

    Time frame: Baseline, end of week 10

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

  6. Body composition and anthropometrics: Appendicular lean mass

    Time frame: Baseline, end of week 10

    Changes in appendicular lean mass, assessed by DXA

  7. Body composition and anthropometrics: Total fat mass

    Time frame: Baseline, end of week 10

    Changes in total fat mass, assessed by DXA

  8. Body composition and anthropometrics: Fat percentage

    Time frame: Baseline, end of week 10

    Changes in fat percentage, assessed by DXA

  9. Body composition and anthropometrics: Bone mineral density

    Time frame: Baseline, end of week 10

    Changes in bone mineral density, assessed by DXA

  10. Body composition and anthropometrics: Muscle thickness

    Time frame: Baseline, end of week 10

    Changes in thickness of the vastus lateralis, assessed by ultrasound

  11. Body composition and anthropometrics: Skeletal muscle index

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

    Changes in skeletal muscle index, assessed by diagnostic CT scans

  12. Body composition and anthropometrics: Skeletal muscle attenuation

    Time frame: At diagnose, end of week 10

    Changes in skeletal muscle attenuation, assessed by diagnostic CT scans

  13. Body composition and anthropometrics: Adipose tissue index

    Time frame: At diagnose, end of week 10

    Changes in adipose tissue index, assessed by diagnostic CT scans

  14. Body composition and anthropometrics: Body mass

    Time frame: Baseline, end of week 10

    Changes in body mass

  15. Body composition and anthropometrics: Body mass index

    Time frame: Baseline, end of week 10

    Changes in body mass index

  16. Body composition and anthropometrics: Hip circumference

    Time frame: Baseline, end of week 10

    Changes in hip circumference

  17. Body composition and anthropometrics: Waist circumference

    Time frame: Baseline, end of week 10

    Changes in waist circumference

  18. Muscle strength: Leg press maximal muscle strenght

    Time frame: Baseline, end of week 10

    Changes in leg press one repetition maximum (1RM)

  19. Muscle strength: Chest press maximal muscle strenght

    Time frame: Baseline, end of week 10

    Changes in chest press 1RM

  20. Muscle strength: Hand grip strenght

    Time frame: Baseline, end of week 10

    Changes in hand grip strength, assessed using a dynamometer

  21. Functional performance: Habituel gait speed

    Time frame: Baseline, end of week 10

    Changes in habitual gait speed

  22. Functional performance: Maximal gait speed

    Time frame: Baseline, end of week 10

    Changes in maximal gait speed

  23. Functional performance: Sit-to-stand

    Time frame: Baseline, end of week 10

    Changes in sit-to-stand power.

  24. Functional performance: Stair climb

    Time frame: Baseline, end of week 10

    Changes in stair climbing power

  25. Resting metabolic rate

    Time frame: Baseline, end of week 10

    Changes in resting metabolic rate

  26. Blood pressure: Systolic blood pressure

    Time frame: Baseline, end of week 10

    Changes in systolic blood pressure

  27. Blood pressure: Diastolic blood pressure

    Time frame: Baseline, end of week 10

    Changes in diastolic blood pressure

  28. Heart rate

    Time frame: Baseline, end of week 10

    Changes in resting heart rate

  29. 1 and 2-years cancer-specific survival

    Time frame: Randomization to 1 and 2 years after randomization

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

  30. 1 and 2-years over-all survival

    Time frame: Randomization to 1 and 2 years after randomization

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

  31. Progression-free survival

    Time frame: Randomization to 2 years after randomization

    Time to progression

  32. Treatment tolerance: Hospitalization

    Time frame: 3, 6 and 9 weeks after randomization

    Unscheduled hospitalization

  33. Treatment tolerance: Relative dose intensity

    Time frame: 3, 6 and 9 weeks after randomization

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

  34. Treatment tolerance: Number of series recieved

    Time frame: 3, 6 and 9 weeks after randomization

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

  35. Treatment tolerance: Tolerated dose

    Time frame: 3, 6 and 9 weeks after randomization

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

  36. Treatment tolerance: Permanent discontinuation of the treatment

    Time frame: 3, 6 and 9 weeks after randomization

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

  37. Treatment effect: Response to chemotherapy

    Time frame: Randomization to 2 years after randomization

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

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

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

    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)

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

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

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

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

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

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

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

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

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

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

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

    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)

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

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

    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)

  44. Depression

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

    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)

  45. Anxiety

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

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

  46. Self-reported physical activity: Walking

    Time frame: Baseline, end of week 10

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

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

    Time frame: Baseline, end of week 10

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

  48. Self-reported physical activity: Vigorous intensity PA

    Time frame: Baseline, end of week 10

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

  49. Self-reported physical activity: Total PA

    Time frame: Baseline, end of week 10

    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)

  50. Self-reported physical activity: Sitting time

    Time frame: Baseline, end of week 10

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

  51. Self-reported screening of sarcopenia

    Time frame: Baseline, end of week 10

    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)

  52. Self-reported three-days dietary records

    Time frame: Baseline, week 5 and week 10

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

  53. Patient-reported symptomatic adverse events

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

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

Other outcomes

  1. Blood biochemistry: Leukocyte differential counts

    Time frame: Baseline, end of week 10

    Changes in differential counts (total and per type: eosinofils, basofils, neutrofils, monocytes and lymphocytes)

  2. Blood biochemistry: C-reactive protein

    Time frame: Baseline, end of week 10

    Changes in C-reactive protein

  3. Blood biochemistry: albumin and protein

    Time frame: Baseline, end of week 10

    Changes in albumine and protein

  4. Blood biochemistry: magnesium and phosphate

    Time frame: Baseline, end of week 10

    Changes in magnesium and phosphate

  5. Blood biochemistry: Total cholesterol

    Time frame: Baseline, end of week 10

    Changes in total cholesterol

  6. Blood biochemistry: Low-density lipoprotein cholesterol

    Time frame: Baseline, end of week 10

    Changes in low-density lipoprotein cholesterol

  7. Blood biochemistry: High-density lipoprotein cholesterol

    Time frame: Baseline, end of week 10

    Changes in high-density lipoprotein cholesterol

  8. Blood biochemistry: Triglyceride

    Time frame: Baseline, end of week 10

    Changes in triglyceride

  9. Blood biochemistry: Glycated hemoglobin A1c

    Time frame: Baseline, end of week 10

    Changes in glycated hemoglobin A1c

  10. Blood biochemistry: Insulin

    Time frame: Baseline, end of week 10

    Changes in insulin

  11. Blood biochemistry: Glucose tolerance

    Time frame: Baseline, end of week 10

    Changes in glucose tolerance (2-hpur oral glucose tolerance test)

  12. Blood biochemistry: Glucose

    Time frame: Baseline, end of week 10

    Changes in glucose

  13. Blood biochemistry: C-peptide

    Time frame: Baseline, end of week 10

    Changes in c-peptide

  14. Blood biochemistry: Interleukin-1

    Time frame: Baseline, end of week 10

    Changes in interlieukin-1

  15. Blood biochemistry: Interleukin-6

    Time frame: Baseline, end of week 10

    Changes in interlieukin-6

  16. Blood biochemistry: Interleukin-8

    Time frame: Baseline, end of week 10

    Changes in interlieukin-8

  17. Blood biochemistry: Interleukin-10

    Time frame: Baseline, end of week 10

    Changes in interlieukin-10

  18. Blood biochemistry: Interferon-gamma

    Time frame: Baseline, end of week 10

    Changes in interferon-gamma

  19. Blood biochemistry: Tumor necrosis factor-alpha

    Time frame: Baseline, end of week 10

    Changes in tumor necrosis factor-alpha

  20. Blood biochemistry: Circulating tumor DNA

    Time frame: Baseline, week 5 and 10

    Changes in circulating tumor DNA

  21. Effect of acute exercise: Insulin sensitivity

    Time frame: Immediately after acute exercise

    Muscle glucose uptake during insulin stimulation after acute exercise

  22. Effect of acute exercise: muscle protein synthesis

    Time frame: Immediately after acute exercise

    Muscle protein synthesis during insulin stimulation after acute exercise.

  23. Changes of proteins in muscle biopsies

    Time frame: Before and immediately after acute exercise

    Modifications of proteins after acute exercise. Muscle biopsies will be subjected to mass spectrometry-based proteomic analysis.

  24. Changes of proteins in mithocondrial regulation

    Time frame: Before and immediately after acute exercise

    Modifications of mithochondrial regulation. Signaling of mitochondiral fission, fusion and mitophagy will be examined in mucle biopsies.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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