Trial Title:
The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
NCT ID:
NCT06138223
Condition:
GastroEsophageal Cancer
Incurable Disease
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
gastroesophageal cancer
GAC
Palliative
exercise intervention
nutritional intervention
Quality of life
QOL
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise intervention
Description:
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.
Arm group label:
Combined exercise and nutritional intervention.
Intervention type:
Other
Intervention name:
Nutrition intervention
Description:
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.
Arm group label:
Combined exercise and nutritional intervention.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Zip:
1081HV
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Hanneke van Laarhoven
Phone:
020 444 43 21
Email:
h.vanlaarhoven@amsterdamumc.nl
Facility:
Name:
Reinier de Graaf
Address:
City:
Delft
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
AJ Verschoor
Facility:
Name:
HagaZiekenhuis
Address:
City:
Den Haag
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
D Houtsma, Dr
Facility:
Name:
Catharina Ziekenhuis
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
IEG van Hellemond
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Hoofddorp
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Medisch Centrum Leeuwarden
Address:
City:
Leeuwarden
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Leiden Universitair Medisch Centrum
Address:
City:
Leiden
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M Slingerland, Dr
Facility:
Name:
Canisius Wilhelmina Ziekenhuis
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Johan Janssen, Dr
Facility:
Name:
Laurentius Ziekenhuis
Address:
City:
Roermond
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
MHW van de Poel, Dr
Facility:
Name:
Bravis Ziekenhuis
Address:
City:
Roosendaal
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
Ikazia Ziekenhuis
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J.C. Drooger, Dr
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Zip:
3508GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Anne May
Email:
MaA.M.May@umcutrecht.nl
Start date:
January 1, 2024
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06138223
https://nvdietist.nl/app/uploads/2021/03/Algemene_Voedings-_en_dieetbehandeling_.pdf
