The aim of the RADICES study is to investigate the effects of a 12-week exercise and nutrition intervention for patients with metastatic oesophageal or gastric cancer. The intervention will be completely tailored to the condition and nutritional…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life.
Secondary outcome
Physical effects
1. Aerobic capacity
2. Muscle strength
3. Muscle mass and fat mass
4. Weight
5. Nutritional status including sarcopenia
6. Physical activity
7. Toxicity
8. WHO performance status
Patient reported outcomes
1. Physical activity
2. Physical functioning, role functioning and fatigue
Medical effects
1. Percentage of patients starting systemic treatment
2. Dose reductions and delays
3. Duration of systemic therapy
4. Progression free and overall survival
Exploratory endpoints
1. Other Patient Reported Outcomes as measured by the POCOP questionnaire
2. Dietary intake
3. Cost efficacy
Intervention group only:
1. (Serious) Adverse events potentially related to the exercise intervention
2. Satisfaction with the exercise and nutritional intervention (intervention
group only)
3. Adherence and compliance to the exercise and diet intervention
Background summary
We know that exercise is safe for patients with non-metastatic cancer and that
it has a positive effect on the disease and treatment-related side effects.
Exercise has been shown to have a positive effect in people treated for
non-metastatic esophageal cancer. They are less tired, are fitter and
experience a better quality of life. However, we know little about what
exercise in combination with nutrition can mean for patients with metastatic
oesophageal or gastric cancer. It is possible that exercise in combination with
nutrition in these patients also improves their quality of life, but we do not
know that at the moment.
Study objective
The aim of the RADICES study is to investigate the effects of a 12-week
exercise and nutrition intervention for patients with metastatic oesophageal or
gastric cancer. The intervention will be completely tailored to the condition
and nutritional status of the patient. We will look at what this combined
intervention does to quality of life and other aspects related to the disease
and the treatment of the patients.
Study design
When the patient chooses to participate in the RADICES study, the patient will
be randomly assigned to one of two groups:
1. Intervention group
2. Control group
The intervention in this study is a 12-week exercise and nutrition intervention
(described below). The effects of this intervention on the quality of life of
patients in the intervention group are compared with the control group. All
participants, in both groups, will receive usual medical care and treatment.
Intervention
The intervention in this study is a 12-week exercise and nutrition
intervention. Exercise intervention: the patient trains for an hour twice a
week under the supervision of a physiotherapist in the area. The program
consists of strength training (eg squats) and endurance training (eg cycling).
During the entire 12-week exercise program, the patient should also exercise
without supervision, i.e. at least 30 minutes a day. When moving without
guidance, the patient receives help from an exercise meter (Fitbit).
Nutritional intervention: The dietitian will assess the patient's nutritional
status and based on this, formulate personal nutrition-related goals together
with the patient. The patient receives concrete advice about the composition of
your diet, the number of meal times and the aim is to consume a suitable amount
of energy and protein for the patient. If necessary, medical nutrition (such as
liquid nutrition or tube feeding) is also used for this purpose. After training
a bolus protein intake is adviced.
If the patient is assigned to the control group, he will receive an exercise
meter (Fitbit), exercise advice that encourages the patient to exercise and
information about nutrition as is customary in their own hospital.
For the examination it is necessary that the patient comes to the hospital 2
times in 3 months. A visit takes about 2 to 3 hours. During these visits the
following happens:
- We do a physical examination and measure fitness:
o We measure height, weight, heart rate, blood pressure and muscle and fat mass.
o We do a number of standard tests so that we can determine physical fitness
- Complete questionnaires
o We will ask the patient to complete standardized questionnaires at baseline,
at 6 weeks, three months and then every three months. During the intervention
period there is also a short list that is administered every two weeks.
o We ask the patient to keep a detailed food diary two times over 3 days
Study burden and risks
We do not expect the intervention to have adverse effects on the participants,
except for the necessary time investment, possible muscle or joint injuries and
feeling *full* due to the nutritional intervention. Current exercise-oncology
guideline state that the risk of adverse events when exercise during treatment
is low.(9) The physiotherapist will prevent injuries and adjust the training
schedule if necessary and so will the dietician regarding the dietatery
measures. Potential benefits for the participants in this study include better
QOL, longer duration of anticancer treatment and longer survival.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Incurable adenocarcinoma of the esophagus or stomach.
• Progressive disease after treatment with curative intent OR metastatic
disease at primary diagnosis.
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06138223 |
| CCMO | NL83835.018.23 |