Clinical trial NCT05650827: Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Official title: Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastro-esophageal Cancer
Keywords: Exercise oncology
Resistance exercise
Cancer
Cancer cachexia
Protein supplements
Sarcopenia
Palliative chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise feasibility: Exercise sessions attendance
timeFrame: From baseline until end of intervention (10 weeks)
measure: Exercise feasibility: Relative dose-intensity of protein supplement
timeFrame: From baseline until end of intervention (10 weeks)
measure: Incidence of Serious Adverse Events (SAEs).
timeFrame: Baseline until end of intervention (10 weeks)
Secondary outcomes:
measure: Exercise feasibility: Relative dose intensity of exercise
timeFrame: Baseline until end of intervention (10 weeks)
measure: Exercise feasibility: Early termination of exercise sessions
timeFrame: Baseline until end of intervention (10 weeks)
measure: Exercise feasibility: Exercise intervention interruptions
timeFrame: Baseline until end of intervention (10 weeks)
measure: Exercise feasibility: Permanent discontinuation
timeFrame: Baseline until end of intervention (10 weeks)
measure: Body composition and anthropometrics: Total lean mass
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Appendicular lean mass
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Total fat mass
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Fat percentage
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Bone mineral density
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Muscle thickness
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Skeletal muscle index
timeFrame: At diagnose, after 10 weeks intervention and at 1 year follow up
measure: Body composition and anthropometrics: Skeletal muscle attenuation
timeFrame: At diagnose, end of week 10
measure: Body composition and anthropometrics: Adipose tissue index
timeFrame: At diagnose, end of week 10
measure: Body composition and anthropometrics: Body mass
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Body mass index
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Hip circumference
timeFrame: Baseline, end of week 10
measure: Body composition and anthropometrics: Waist circumference
timeFrame: Baseline, end of week 10
measure: Muscle strength: Leg press maximal muscle strenght
timeFrame: Baseline, end of week 10
measure: Muscle strength: Chest press maximal muscle strenght
timeFrame: Baseline, end of week 10
measure: Muscle strength: Hand grip strenght
timeFrame: Baseline, end of week 10
measure: Functional performance: Habituel gait speed
timeFrame: Baseline, end of week 10
measure: Functional performance: Maximal gait speed
timeFrame: Baseline, end of week 10
measure: Functional performance: Sit-to-stand
timeFrame: Baseline, end of week 10
measure: Functional performance: Stair climb
timeFrame: Baseline, end of week 10
measure: Resting metabolic rate
timeFrame: Baseline, end of week 10
measure: Blood pressure: Systolic blood pressure
timeFrame: Baseline, end of week 10
measure: Blood pressure: Diastolic blood pressure
timeFrame: Baseline, end of week 10
measure: Heart rate
timeFrame: Baseline, end of week 10
measure: 1 and 2-years cancer-specific survival
timeFrame: Randomization to 1 and 2 years after randomization
measure: 1 and 2-years over-all survival
timeFrame: Randomization to 1 and 2 years after randomization
measure: Progression-free survival
timeFrame: Randomization to 2 years after randomization
measure: Treatment tolerance: Hospitalization
timeFrame: 3, 6 and 9 weeks after randomization
measure: Treatment tolerance: Relative dose intensity
timeFrame: 3, 6 and 9 weeks after randomization
measure: Treatment tolerance: Number of series recieved
timeFrame: 3, 6 and 9 weeks after randomization
measure: Treatment tolerance: Tolerated dose
timeFrame: 3, 6 and 9 weeks after randomization
measure: Treatment tolerance: Permanent discontinuation of the treatment
timeFrame: 3, 6 and 9 weeks after randomization
measure: Treatment effect: Response to chemotherapy
timeFrame: Randomization to 2 years after randomization
measure: Health-related quality of life: Physical well-being
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Health-related quality of life: Social well-being
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Health-related quality of life: Emotional well-being
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Health-related quality of life: Functional well-being
timeFrame: Baseline,10 weeks-, 1 year-, 2 years after randomization
measure: Health-related quality of life: gastroesophageal cancer specific
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Health-related quality of life: cancer cachexia specific
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Depression
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Anxiety
timeFrame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
measure: Self-reported physical activity: Walking
timeFrame: Baseline, end of week 10
measure: Self-reported physical activity: Moderate intensity physical activity (PA)
timeFrame: Baseline, end of week 10
measure: Self-reported physical activity: Vigorous intensity PA
timeFrame: Baseline, end of week 10
measure: Self-reported physical activity: Total PA
timeFrame: Baseline, end of week 10
measure: Self-reported physical activity: Sitting time
timeFrame: Baseline, end of week 10
measure: Self-reported screening of sarcopenia
timeFrame: Baseline, end of week 10
measure: Self-reported three-days dietary records
timeFrame: Baseline, week 5 and week 10
measure: Patient-reported symptomatic adverse events
timeFrame: One week after each serie of chemotherapy during the intervention (10 weeks)
Other outcomes:
measure: Blood biochemistry: Leukocyte differential counts
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: C-reactive protein
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: albumin and protein
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: magnesium and phosphate
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Total cholesterol
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Low-density lipoprotein cholesterol
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: High-density lipoprotein cholesterol
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Triglyceride
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Glycated hemoglobin A1c
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Insulin
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Glucose tolerance
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Glucose
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: C-peptide
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Interleukin-1
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Interleukin-6
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Interleukin-8
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Interleukin-10
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Interferon-gamma
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Tumor necrosis factor-alpha
timeFrame: Baseline, end of week 10
measure: Blood biochemistry: Circulating tumor DNA
timeFrame: Baseline, week 5 and 10
measure: Effect of acute exercise: Insulin sensitivity
timeFrame: Immediately after acute exercise
measure: Effect of acute exercise: muscle protein synthesis
timeFrame: Immediately after acute exercise
measure: Changes of proteins in muscle biopsies
timeFrame: Before and immediately after acute exercise
measure: Changes of proteins in mithocondrial regulation
timeFrame: Before and immediately after acute exercise
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Copenhagen University Hospital, Rigshospitalet, Denmark
name: Casper Simonsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: