Peripheric NeuropathyCANALOXANCT02827916
Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach
A study testing Assessment of neuropathic pain with theThermotest device, Assessment of neuropathic pain with SUDOSCAN device and Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. in people with Peripheric Neuropathy and Chemo-induced Neuropathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheric Neuropathy, Chemo-induced Neuropathy
- What is being tested?
- Assessment of neuropathic pain with theThermotest device, Assessment of neuropathic pain with SUDOSCAN device and Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient newly treated with oxaliplatin
- Patient suffering from any type of cancer treated with oxaliplatin
- Man or Woman over 18
Who cannot join
- Patient with brain or leptomeningeal metastases
- Patient previously treated with cisplatin
- Patient addicted to alcohol
- Diabetic patient with peripheral neurological disorders
- Patient receiving calcium or magnesium salts intravenously
- Patient suffering from peripheral neuropathy
- Patient suffering from psychiatric disorders
- Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the detailed description
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
- 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.
- 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.
- 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.
- Conditions
- Peripheric Neuropathy, Chemo-induced Neuropathy
- Being tested
- Assessment of neuropathic pain with theThermotest device, Assessment of neuropathic pain with SUDOSCAN device, Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of neuropathic pain with theThermotest deviceDevice
Measure of painful neuropathy with thermotest
Assessment of neuropathic pain with SUDOSCAN deviceDevice
Measure of painful neuropathy with sudoscan Devices
Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.Device
Measure of painful neuropathy with Neuropathic Pain Symptom Inventory.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory. Receives: Device: Assessment of neuropathic pain with theThermotest device; Device: Assessment of neuropathic pain with SUDOSCAN device; Device: Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of neuropathy by electrophysiological methods using SUDOSCAN
The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain
Measured: Day 1
Secondary outcomes (2)
Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain
The pain symptoms are evaluated through various semi- objective neuropathy quantification tools (Quantitative Sensory Testing devices)6 :
- Le 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 hypoesthesia in chroniqe) are typical of oxaliplatin, Thermotest is fundamental.
Measured: Day 1
NPSI ange of Characterization of pain neuropathy
Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field and validated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start4 Apr 2016
- Primary completion13 Apr 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheric NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- COUDORE Francois, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827916
- Sponsor's protocol ID
- CANALOXA
- Acronym
- CANALOXA
- Status last verified
- Sep 2017
- First submitted
- 29 Jun 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Delmotte JB, Tutakhail A, Abdallah K, Reach P, D'Ussel M, Deplanque G, Beaussier H, Coudore F. Electrochemical Skin Conductance as a Marker of Painful Oxaliplatin-Induced Peripheral Neuropathy. Neurol Res Int. 2018 Sep 27;2018:1254602. doi: 10.1155/2018/1254602. eCollection 2018.
PubMed 30363900
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach: Interest Using the SUDOSCAN® Machine
- ClinicalTrials.gov ID
- NCT02827916
- Acronym / sponsor ID
- CANALOXA / CANALOXA
- Conditions
- Peripheric Neuropathy, Chemo-induced Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Assessment of neuropathic pain with theThermotest device, Device: Assessment of neuropathic pain with SUDOSCAN device, Device: Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient newly treated with oxaliplatin
- Patient suffering from any type of cancer treated with oxaliplatin
- Man or Woman over 18
Key exclusion criteria (8 listed)
- Patient with brain or leptomeningeal metastases
- Patient previously treated with cisplatin
- Patient addicted to alcohol
- Diabetic patient with peripheral neurological disorders
- Patient receiving calcium or magnesium salts intravenously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of neuropathic pain with theThermotest deviceMeasure of painful neuropathy with thermotest | Device | All patients |
| Assessment of neuropathic pain with SUDOSCAN deviceMeasure of painful neuropathy with sudoscan Devices | Device | All patients |
| Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.Measure of painful neuropathy with Neuropathic Pain Symptom Inventory. | Device | All patients |
Primary outcome
Evaluation of neuropathy by electrophysiological methods using SUDOSCAN
Time frame: Day 1
The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain
2 secondary outcomes
Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain
Time frame: Day 1
NPSI ange of Characterization of pain neuropathy
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 30363900Delmotte JB, Tutakhail A, Abdallah K, Reach P, D'Ussel M, Deplanque G, Beaussier H, Coudore F. Electrochemical Skin Conductance as a Marker of Painful Oxaliplatin-Induced Peripheral Neuropathy. Neurol Res Int. 2018 Sep 27;2018:1254602. doi: 10.1155/2018/1254602. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COUDORE Francois, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of neuropathic pain with theThermotest device, Assessment of neuropathic pain with SUDOSCAN device and Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. in people with Peripheric Neuropathy and Chemo-induced Neuropathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of neuropathy by electrophysiological methods using SUDOSCAN (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.