The objective of this study is to Identify relevant geriatric instruments and compose a clinical model to predict tolerance and toxicity in elderly cancer patients who are treated with chemotherapy for their (metastasized) malignancy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is chemotherapy tolerance, defined as the ability to complete
the first three cycles. This will then be correlated to the scores from the
questionnaires.
Secondary outcome
Secondary outcome is (CTCAE graded) toxicity. This will then be correlated to
the scores from the questionnaires.
Background summary
Due to the aging of many western populations the number of people above 65
years of age is rapidly increasing. Furthermore high age is associated with
increased cancer risk. With increasing age, physiological reserves decrease and
people become more vulnerable to disease and stress, resulting in more
co-morbidities. This makes elderly patients a very heterogeneous group. Because
of this advanced age is one of the major exclusion criteria of many large
clinical trials. However, as a resultcurrent knowledge about chemotherapy
tolerance and toxicity in elderly is limited and oncology lacks proper clinical
instruments to accurately and objectively differentiate between fit and frail
elderly patients
Study objective
The objective of this study is to Identify relevant geriatric instruments and
compose a clinical model to predict tolerance and toxicity in elderly cancer
patients who are treated with chemotherapy for their (metastasized) malignancy.
Study design
Multi-center prospective cohort study. For development of the predictive model
we will use five validated questionnaires about health and functioning and a
short validated mobility test from geriatric medicine. Assessment will be
preceding chemotherapeutic treatment. Furthermore information from the medical
record will be used. No extra invasive measurements will be made for this
study.
Study burden and risks
Expectation is participation to this study will have negligible risks and no
advantages or disadvantages for the participants. Participating requires a one
time investment of 30-60 minutes. Treatment does not depend on this study.
There are no invasive measurements.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Patients with a metastasized malignancy that will be treated with palliative chemotherapy.
- Patients with a non hogdkin lymphoma or a multiple myeloma that will be treated with chemotherapy
- Patients that are at least 70 years old at start of chemotherapy.
- Informed consent.
Exclusion criteria
- Patients who have unadequate command of the Dutch language.
- Patients who are cognitive impaired.
- Patients with CNS metastases.
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 | NL42055.100.12 |