The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed. However, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment. A total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.
Randomization will be stratified based on: duration of first line therapy (shorter or longer than 6 months), WHO performance status (0, 1 versus 2), (intended) start of second-line (or further) systemic therapy for progressive disease (yes versus no) and time since failure of first line therapy (shorter or longer than 3 months ago). Due to the nature of the intervention, it is not possible to blind the patients, the local study nurses, or the investigators to the treatment assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
196
During 12 weeks, patients will visit twice a week a trained oncology physiotherapist for one hour per session. This training includes supervised aerobic and resistance exercises to increase aerobic condition and muscle resistance, based on their own fitness level as assessed at baseline. Additionally, physiotherapists will educate participants on how to increase their daily activity. To this end, all participants will receive an activity tracker to monitor their daily activities.
Once every two weeks patients in the intervention group will receive a nutritional assessment and intervention by a trained dietician for optimization of their nutritional intake to improve their nutritional status, following the ESPEN guideline on nutrition in cancer patients and the national guidelines of the National Nutritionists Oncology Working Group (NNOWG; in Dutch: Landelijke Werkgroep Diëtisten Oncologie, LWDO). Moreover, an amount of 15-25 grams of protein within 1-2 hours after exercise will be advised, to prevent muscle protein breakdown and enhance muscle protein synthesis.
Amsterdam UMC
Amsterdam, North Holland, Netherlands
RECRUITINGReinier de Graaf
Delft, Netherlands
RECRUITINGCatharina Ziekenhuis
Eindhoven, Netherlands
NOT_YET_RECRUITINGSpaarne Gasthuis
Hoofddorp, Netherlands
ACTIVE_NOT_RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Netherlands
ACTIVE_NOT_RECRUITINGLeiden Universitair Medisch Centrum
Leiden, Netherlands
NOT_YET_RECRUITINGCanisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
RECRUITINGLaurentius Ziekenhuis
Roermond, Netherlands
RECRUITINGBravis Ziekenhuis
Roosendaal, Netherlands
ACTIVE_NOT_RECRUITINGIkazia Ziekenhuis
Rotterdam, Netherlands
RECRUITING...and 2 more locations
Quality of life (EORTC-QLQ-30) summary score
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item. The summary score encompasses the last question of this questionnaire. Scale: 1-7 Higher score means better quality of life. Analyzed will be the difference in quality of life between the intervention group and the control group at 12 weeks, taking into account the baseline values, and measured with the Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: Baseline, 6 weeks and every 12 weeks up to one year after intervention
Aerobic capacity: MSEC
Changes in MSEC (= maximum short exercise capacity or in other words maximum wattage in the steep ramp test). In the steep ramp test participants cycle with a pedal frequency between 70 and 80 rpm 30 seconds at 25 W. Then every 10 seconds, the load is increased with 25 W until exhaustion. The test ends when pedal frequency falls below 60 rpm. From the MSEC peak Wattage (Wpeak) can be estimated using a regression equation. Scale: 0-500 W
Time frame: Baseline, 12 weeks
Muscle strength: Hand grip strength
Changes in hand grip strength. Hand grip strength: using a handgrip dynamometer the participant will be asked to squeeze the dynamometer as hard as possible for three times, for both hands. The best of three attempts for bot hands is recorded. Scale: 0-100 kg.
Time frame: Baseline, 12 weeks
Body composition: Muscle mass
Muscle mass will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-100 kg
Time frame: Baseline, 12 weeks
Body composition: Fat mass
Fat mass will be measured with the validated InBody Dial H20B Smart Scale. Scale: 1-100 kg
Time frame: Baseline, 12 weeks
Body composition: Weight
Weight will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-200 kg
Time frame: Baseline, 12 weeks
Self-reported screening of malnutrition
Malnutrition will be screened using the short-form Abridged Scored Patient-Generated Subjective Global Assessment (abPG-SGA). Scale: 0-50 Higher score is more malnourished
Time frame: Baseline and every 12 weeks up to one year after intervention
Physical activity
Physical activity is measured by an activity tracker (Fitbit). Participants are instructed to wear the tracker for 12 weeks. Mean daily steps and minutes spent in different intensity levels of physical activity are calculated, excluding no-wear days.
Time frame: Baseline, 12 weeks
WHO performance status
Changes in WHO performance status.
Time frame: Baseline and during the intervention, until the end of the intervention (12 weeks).
Quality of life (EORTC-QLQ-30) total score
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item. Changes in total quality of life. Scale: 0-100 Higher score means better quality of life.
Time frame: Baseline, 6 weeks and every 12 weeks up to one year after intervention
Self-reported screening of sarcopenia
Changes in sarcopenia will be assessed using the Sarc-F questionnaire. (Scale 0-10, higher the score the better the condition).
Time frame: Baseline,12 weeks
Skeletal muscle index
Changes in skeletal muscle index, assessed by diagnostic CT-scans.
Time frame: Baseline, 12 weeks.
Muscle strength: leg press maximal muscle strength
Changes in leg press one repetition maximum (1RM). Leg strength: the 12 repetition maximum is the maximum weight with which exactly 12 repetitions of a defined exercise/movement sequence can be performed with clean technique. Afterwards, the so called hypothetical 1RM (h1RM) can be calculated. Scale: 0-200 kg
Time frame: Baseline, 12 weeks
Medical effects: Treatment toxicity
Changes in treatment toxicity in case of start of second line systemic treatment will be assessed using the Common Terminology Criteria for Adverse Events version 5.0
Time frame: Baseline up to one year after intervention
Medical effects: percentage of patients starting second-line treatment
Percentage of patients who have started second-line treatment
Time frame: Baseline up to one year after intervention
Medical effects: dose reductions
Treatment tolerance assessed by the amount of delivered second-line systemic treatment doses.
Time frame: Baseline up to one year after intervention
Medical effects: dose delays
Treatment tolerance assessed by the number of dose delays of second-line systemic treatment.
Time frame: Baseline up to one year after intervention
Medical effects: duration of systemic therapy
Treatment tolerance assessed by the total duration of second-line systemic treatment.
Time frame: Baseline up to one year after intervention
Progression-free survival
Time to progression
Time frame: Baseline up to one year after intervention
Overall survival
Proportion of patients who have not died 1 year after baseline.
Time frame: Baseline up to 1 year after intervention.
Patient reported physical activity
Physical activity will be assessed by the validated and reliable Short Questionnaire to assess health enhancing physical activity (SQUASH) including commuting activities, leisure time activities, household activities, and activities at work and school.
Time frame: Baseline and every 12 weeks up to one year after intervention
Health-related quality of life: physical functioning
Changes in physical functioning, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, physical functioning will be assessed using computer adaptive testing in collaboration with experts of the EORTC.
Time frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
Health-related quality of life: role functioning
Changes in role functioning, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, role functioning will be assessed using computer adaptive testing in collaboration with experts of the EORTC.
Time frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
Health-related quality of life: fatigue
Changes in fatigue, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, fatigue will be assessed using computer adaptive testing in collaboration with experts of the EORTC.
Time frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
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