Main study objective: to explore the compliance to nutritional test product intake after the first 3 cycles of systemic therapy in patients with metastatic colorectal cancer receiving first line of CAP-containting systemic treatment. Other study…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
kanker cachexie, ondervoeding bij kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Compliance to nutritional test product intake as measured by:
- The eicosapentaenoic acid (EPA) concentration in the phospholipid fraction of
the erythrocyte membrane [% of total fatty acids] after the first 3 cycles of
CAP-containing treatment (measured in both study groups)
- Test product intake as recorded by the patient in a daily diary after the
first 3 cycles of CAP-containing treatment. The actual test product intake
after the first 3 cycles of CAP-containing treatment as compared to the (as per
protocol) recommended intake will be evaluated.
Secondary outcome
- Body weight [kg]
- Body composition from CT scan: skeletal muscle mass; fat mass; muscle density
- Quality of Life and symptoms: European Organization for Research and
Treatment of Cancer quality of life questionnaire (EORTC) QLQ-C30
and EORTC QLQ-CR29
- Performance status (WHO/ECOG)
- Dietary intake by 3-day dietary record
- Blood parameters
- Evaluation of study participation including experienced changes in sensory
aspects and taste perception.
Background summary
Recent studies show that muscle mass decreases significantly during palliative
systemic treatment in patients with metastatic colorectal cancer. Observational
studies suggest that low muscle mass is associated with dose-limiting
treatment-related toxicity and poor survival in patients with colorectal cancer
undergoing systemic treatment. Therefore, it is important to increase or at
least maintain muscle mass during chemotherapy. The medical nutrition
supplement that will be studied in the current clinical trial, has been
developed to improve or maintain muscle mass as well as body weight and through
this to benefit other outcomes, such as quality of life. The current study has
been developed with the main focus to investigate the compliance to intake of
the medical nutrition supplement in patients with metastatic colorectal cancer
after the first 3 cycles of first line capecitabine-containing (CAP-containing)
treatment.
Study objective
Main study objective: to explore the compliance to nutritional test product
intake after the first 3 cycles of systemic therapy in patients with metastatic
colorectal cancer receiving first line of CAP-containting systemic treatment.
Other study objectives: to explore the effect of the test product in patients
with metastatic colorectal cancer receiving first line of CAP-containing
systemic treatment in comparison with a control group receiving standard of
care treatment, on tolerance and safety; systemic treatment related parameters;
body weight and body composition; quality of life; dietary intake; blood
chemistry.
Study design
The study is a randomized controlled open-label parallel-group single-centre
exploratory study in 1 study centre with multiple satellite centres.
Intervention
The test group will be asked to take the medical nutrition supplement twice per
day, during the first 3 cycles of CAPOX-B treatment. The control group receives
the same medical CAP-containing treatment and standard of care of nutritional
support.
Study burden and risks
Patients in the test group will be asked to take the medical nutrition
supplement twice daily, during the first 3 cycles of CAP-containing treatment.
The control group receives the same medical CAP-containing treatment and
standard of care of nutritional support. Patients in the control group will
undergo the same assessments throughout the 3 cycles of systemic treatment as
patients in the test group. Most of the study assessments are performed during
routine hospital visits required for the treatment of the disease. Study
specific assessments are: additional blood withdrawal, (only applicable for the
test group:) daily recording of test product intake in a diary, and for both
study groups: completing one 3 day dietary record, questionnaires to record
gastro-intestinal symptoms, questionnaires to assess quality of life. Patients
will also get a study evaluation questionnaire at the end of the study. At the
end of the study, patients will be contacted once by phone. Patients in the
test group who use specific nutritional supplements will be instructed to
replace the use of these supplements by the use of the test product. In
addition, patients in both study groups are not allowed to use fish oil
containing supplements or consume fatty fish > 2x per week and are not allowed
to use specific food supplements during the study. Based on earlier studies
with a similar product, no specific adverse effects are expected. Adverse
events, laboratory safety outcome parameters and the response to chemotherapy
treatment will be evaluated by a physician.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. Histologically proven colorectal cancer
2. Presence of distant metastases
3. Eligible and scheduled for first line treatment with CAP-containing systemic
treatment
4. Performance status (WHO/ECOG) of 0 or 1
5. Age >= 18 years
6. Written informed consent
Exclusion criteria
1. Presence of ileostoma or ileal pouch
2. Malnutrition Univeral Screening Tool (MUST) score of >=2, indicating high
risk of malnutrition
3. Body mass index < 20.0 kg/m2
4. No possibility for the patient to start test product intake 3 days before
start of the first systemic treatment cycle
5. Known intolerance or allergy to dairy, fish, or other ingredients of the
test product
6. Moderate to severe hypercalcemia, i.e. total calcium level >= 12.0 mg/dL
7. Use of fish oil containing supplements or usual consumption of fatty fish >
2x per week, within 3 weeks prior to entry into the study or expected use
during the study
8. Known pregnancy or lactation
9. Current alcohol, drug or medication abuse in opinion of the investigator
10. Investigator*s uncertainty about the willingness or ability of the patient
to comply with the protocol requirements
11. Participation in any other intervention studies involving investigational
or marketed products concomitantly or within two weeks prior to entry into the
study
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 |
|---|---|
| CCMO | NL60251.041.17 |