Clinical trial NCT06138223: The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
Official title: The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GastroEsophageal Cancer
Incurable Disease
Keywords: gastroesophageal cancer
GAC
Palliative
exercise intervention
nutritional intervention
Quality of life
QOL
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
First posted: 2023-11-18
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Incurable adenocarcinoma of the esophagus or stomach.
* 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. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with second/third/etc. line therapy are eligible for inclusion too)
* Able and willing to perform the exercise and nutritional program and wear the activity tracker.
* Able and willing to fill out the POCOP/RADICES questionnaires.
* Life expectancy \> 12 weeks.
* Age ≥ 18 years.

Exclusion Criteria:

* Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.
* Untreated symptomatic known brain metastasis.
* Serious active infection.
* Too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.
* Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.
* Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.
* Uncontrolled severe pain.
* Any other contraindications for exercise as determined by the treating physician.
* Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.
* Pregnancy.

Primary outcomes:
measure: Quality of life (EORTC-QLQ-30) summary score
timeFrame: Baseline, 6 weeks and every 12 weeks up to one year after intervention
Secondary outcomes:
measure: Aerobic capacity: MSEC
timeFrame: Baseline, 12 weeks
measure: Muscle strength: Hand grip strength
timeFrame: Baseline, 12 weeks
measure: Body composition: Muscle mass
timeFrame: Baseline, 12 weeks
measure: Body composition: Fat mass
timeFrame: Baseline, 12 weeks
measure: Body composition: Weight
timeFrame: Baseline, 12 weeks
measure: Self-reported screening of malnutrition
timeFrame: Baseline and every 12 weeks up to one year after intervention
measure: Physical activity
timeFrame: Baseline, 12 weeks
measure: WHO performance status
timeFrame: Baseline and during the intervention, until the end of the intervention (12 weeks).
measure: Quality of life (EORTC-QLQ-30) total score
timeFrame: Baseline, 6 weeks and every 12 weeks up to one year after intervention
measure: Self-reported screening of sarcopenia
timeFrame: Baseline,12 weeks
measure: Skeletal muscle index
timeFrame: Baseline, 12 weeks.
measure: Muscle strength: leg press maximal muscle strength
timeFrame: Baseline, 12 weeks
measure: Medical effects: Treatment toxicity
timeFrame: Baseline up to one year after intervention
measure: Medical effects: percentage of patients starting second-line treatment
timeFrame: Baseline up to one year after intervention
measure: Medical effects: dose reductions
timeFrame: Baseline up to one year after intervention
measure: Medical effects: dose delays
timeFrame: Baseline up to one year after intervention
measure: Medical effects: duration of systemic therapy
timeFrame: Baseline up to one year after intervention
measure: Progression-free survival
timeFrame: Baseline up to one year after intervention
measure: Overall survival
timeFrame: Baseline up to 1 year after intervention.
measure: Patient reported physical activity
timeFrame: Baseline and every 12 weeks up to one year after intervention
measure: Health-related quality of life: physical functioning
timeFrame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
measure: Health-related quality of life: role functioning
timeFrame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
measure: Health-related quality of life: fatigue
timeFrame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).
Other outcomes:
measure: (Serious) Adverse Events potentially related to the exercise intervention
timeFrame: Baseline until the end of intervention (12 weeks)
measure: Adherence and compliance to the exercise and diet intervention
timeFrame: During the intervention period of 12 weeks
measure: Satisfaction with the exercise and nutritional intervention
timeFrame: Post-intervention (12 weeks)
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Amsterdam AMC
name: Hanneke van Laarhoven
role: PRINCIPAL_INVESTIGATOR
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