An interventional study of Exercise intervention and Nutrition intervention in GastroEsophageal Cancer and Incurable Disease, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 22 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Supportive care
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.
After one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence/progression of GAC after curative treatment or irresectable/metastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. Accordingly, we had to alter stratification. The first 23 patients were stratified by: duration of first-line therapy (shorter or longer than 6 months), WHO performance status (0, 1, 2), and intended start of second-line systemic therapy (yes or no). After broadening the criteria, stratification factors were changed to: WHO performance status (0 versus ≥1) and treatment line (first versus second/higher/best supportive care).
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.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Pregnancy.
After one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence/progression of GAC after curative treatment or irresectable/metastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.
The inclusion criterium before broadening was:
Progressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric/esophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too.
Patients randomized to the control group will receive standard medical care, including nutritional care as provided by the center in usual care. Additionally, they receive an activity tracker (like the intervention group) but without specific instructions. We will provide the control patients with written advice on physical activity and diet according to the current guidelines (in short: to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150 min/week).
Intervention: exercise and nutrition program group
Other: Exercise intervention · Other: Nutrition intervention
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.
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).
(Serious) Adverse Events potentially related to the exercise intervention
Adverse events will be monitored and reported according to the Exercise Harms Reporting Method (ExHaRM). Patients in both groups will be asked by the study team about adverse events systematically and in a standardized manner at the follow-up measurement. Patients will be asked by their trainer before and after each supervised session whether any (Serious) Adverse Events occurred during or since the last session (i.e. active surveillance). In addition, trainers will be asked to actively observe for adverse events that may occur during training sessions as well (i.e. passive surveillance). An adverse event panel, consisting of independent exercise and nutritional professionals and clinicians, will review all adverse event forms and determine whether adverse events are indeed potentially causally related to the exercise or nutritional intervention or not.
Time frame: Baseline until the end of intervention (12 weeks)
Adherence and compliance to the exercise and diet intervention
Session attendance and adherence to the planned exercise dose/session. Deviations from the scheduled exercise dose are recorded by the physiotherapist. Attendance rates are computed as the number of supervised exercise sessions attended divided by the number of sessions prescribed and as the number of sessions with the dietician attended divided by the number of sessions prescribed. Compliance will be calculated for the exercise part as the ratio of total completed to total planned cumulative dose for three parts of the RADICES exercise program: duration of aerobic exercises, intensity of aerobic exercises and muscle strength exercises. Compliance will be calculated for the nutritional part as the ratio of total completed to total planned intake of calories, proteins and fat.
Time frame: During the intervention period of 12 weeks
Satisfaction with the exercise and nutritional intervention
Intervention group only. After the 12-week intervention period, we will assess satisfaction with the exercise and nutritional intervention by means of a self-designed questionnaire. The questionnaire contains satisfaction items with regard to the supervised exercise program, the trainer, the activity tracker and the nutritional intervention.
Time frame: Post-intervention (12 weeks)
Plan to share: No
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)