Chemo-induced Neuropathy Clinical Trial
Official title:
Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach: Interest Using the SUDOSCAN® Machine
Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer.
However, the development of neuropathic pain under treatment limits its use. These are
manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.
It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2
channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms
of neurotoxicity are multifactorial and still imperfectly described.
Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose
challenge is to quantify / measure NAION and explained by a biochemical approach,
specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study
insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that
the expected results will be complementary to those of LIPIDOXA.
Main objective:
it is, in cancer patients chronically treated with oxaliplatin (over 5 courses) and
exhibiting signs of neuropathy, to correlate the quantitative changes in the thermal
sensitivity to hot and cold (Thermotest, Quantitative Sensory Testing QST ) with any changes
in the ion conductance chlorine measured by electrophysiological technique (SUDOSCAN).
Secondary objectives:
- Correlating the results obtained with both types of techniques and with the descriptive
parameters of the population included.
- Understand the importance of regulating the activity of the chloride channel in the
development of neuropathy induced by oxaliplatin.
Methodology :
Prospective study, single center, intervention in routine care. Time study: February 2015 -
October 2016
1. Evaluation of neuropathy by electrophysiological methods (SUDOSCAN) The SUDOSCAN is a
new technology fast and non-invasive to quantify the degree of neuropathy objectively
through evaluation of chloride conductance at the skin of the palms and the soles of
pieds4,5.
2. Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain
The pain symptoms was evaluated through various semi-objective neuropathy quantification
tools (Quantitative Sensory Testing devices) 6:
- The Thermotest (Somedic®): medical device that measures the thermal sensitivity
thresholds to cold and hot: cold sensitivity threshold, threshold of sensitivity to
hot, cold pain threshold, pain threshold warm. These stimuli are transmitted by the
fiber Adelta and C. Since dysesthesia to thermal stimuli (allodynia in acute and
chronical hypoesthesia) are typical of oxaliplatin, Thermotest is fundamental.
- Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field
and validated.
3. Statistical Analysis: Professor Gilles Chatellier, statistician (Clinical Research Unit,
Hôpital Européen Georges Pompidou) will bring its expertise in statistical analysis.
NB: For each subject will be awarded an identifier (simple counter: increment as and
measurement of inclusions) and the data will be entered on a computer file which will be sent
to the statistician in charge of the analysis. There will be no exchange of personal data for
this study is single center on the site GHPSJ.
Development of the study:
- Inclusion of patients treated with oxaliplatin from 6th cycle (FOLFOX protocols
FOLFIRINOX, EOX, GEMOX, EOF, XELOX).
- Expected duration of patient recruitment: 9 months
- Number of patients to recruit and duration of participation for each patient: Based on
75 patients seen in 9 months in GHSPJ the oncology department for cancer of the
digestive tract, and knowing that the prevalence of neuropathic pain in oxaliplatin is
50-70% (Attal 2009), the investigators plan to include at least 36 patients in this
period of 9 months.
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