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Patients with Advanced Cancer
Clinical trials should be performed
in a population that resembles as much as possible the population
that will clinically benefit from the use of the intervention
on a daily basis. Patients with advanced cancer often present
with a large variety of severe physical and psychological symptoms.
It is frequently found that a terminally ill patient may simultaneously
have several symptoms, such as severe pain, profound anorexia,
asthenia, chronic nausea, confusion, and anxiety. In addition,
this patient population is in a dynamic state, in which the nature
and intensity of symptoms and the response to the treatment are
changing continuously.
In an effort to better characterize
the biological effects of certain agents and to simplify the design,
trials are frequently performed in younger patients at an earlier
stage of the cancer. The results from these studies are then extrapolated
to the terminally ill patient population. However, these results
can not be applied automatically to patients with advanced illness,
who are in a much more unstable condition and are receiving a
combination of drugs for severe pain and other symptoms, in contrast
to non terminally ill patients.
Stratification of Patient Populations
Patients should be properly characterized
using all known prognostic parameters. The population of patients
should either:
- be stratified according to the
most important prognostic factors, such as presence of
opioid treatment (associated with reversibility) or sepsis or
hypoxia (both associated with reduced reversibility) before
the randomization takes place, or
- multivariate analysis should
be carried out in order to determine the influence of different
prognostic factors on the overall outcome.
Unfortunately, the natural history
of the most frequent symptoms present in terminally ill patients
has not been well characterized.
Click on any of the following choices
to learn more about patient populations that could be used in
studies of delirium.
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