Early Treatment With Invasive Technique in Cancer Pain Management
Status:
Not yet recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
Background: high or moderate intensity pain hits more than a half of patients with cancer and
is not adequately treated way in 1/3 of this patients. Complexity of cancer pain makes right
management difficult and the consequences of an incorrect management are far-reaching in a
clinical and social way. A multimodal treatment tailored on the patient, and the evaluation
of quality of life correlated to different treatment methodologies, must constitute a
decisive element in terms of therapeutic choices.
Over the past 30 years, the World Health Organization (WHO) analgesic step ladder has been
used to guide the choices management of cancer-related pain, but in the last years the growth
of innovative treatment strategies, led to the need to modulate this rigid yet useful system.
Benefits would be obtained with interventional techniques (peripheral neural blockade,
neuromodulatory device use, neuro-destructive techniques, and intrathecal drug delivery
systems) performed in the initial parts of the treatment cycle (before the third step of the
WHO scale), rather than applied according to the WHO scale algorithm. Some authors who
adopted this approach, reported reduction in pain duration and less opioid consumption,
minimizing the risk of opioid related side effects and an improving the overall quality of
life .
The hypothesis is that early application of interventional techniques in oncological patients
has an improving effect in the treatment of chronic cancer pain in terms of efficacy and
quality of life.
Materials and methods: patients followed by the Cancer Pain Therapy Service of the Cancer
National Institute Regina Elena, Rome, with chronic localizable abdominal pain with a value ≥
7 according to the numeric rating scale (NRS) and a diagnosis of untreatable disease will be
randomized into two groups: in the first group patients will be treated with early
interventional neuromodulatory techniques, before high opioids dosages. The other group will
follow the steps of the WHO scale.
Every patient will receive the European Organization for Research and Treatment of Cancer
Quality of life-Core 30 Summary Score (EORTC-QLQ C30) survey to detect quality of life and
the Numeric rate scale NRS. They will receive it before the treatment, after invasive
procedure, one month later and six months later.
Primary end point will be the difference of the quality of life questionnaire score between
the groups; secondary end point will be difference in the NRS values. The statistic analysis
will be based on two groups of patients responding to the including criteria. The sample will
be made of 76 patients divided in two sub-sample of equal dimension to select and analyze in
18 months. The sample thus defined is consistent for a confidence interval of 80% and for a
margin of error of less than 5%.