Neuropathic PainCHEMOSTIMNCT07579611
Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy
A study testing Spinal cord stimulation (FAST mode) in people with Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and debilitating side effect of many cancer treatments. It affects 28 to 48% of patients receiving chemotherapy. Symptoms include tingling, numbness, burning sensations, and pain mainly in the hands and feet. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy (CIPN), Cancer-related Pain
- What is being tested?
- Spinal cord stimulation (FAST mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with chemotherapy-induced painful neuropathy (platinum salts, vincristine, taxanes, alkaloids, epothilone, thalidomide, etc.) evolving for at least 1 year
- Indication for spinal cord stimulation validated by a multidisciplinary team meeting according to SFETD/SFNM guidelines
- Resistance to pharmacological or topical treatment (failure of at least two therapeutic lines or intolerable side effects: anticonvulsants, antidepressants, capsaicin, etc.)
- Pain score > 5/10 on numerical scale in the lower limbs
- Patient able to understand and give informed consent to the protocol
- Patient affiliated to the French Social Security system
- Patient able to complete follow-up questionnaires
Who cannot join
- 1. Contraindication to spinal cord stimulation:
- Extensive laminectomy
- Coagulopathy
- Intercurrent infections
- Psychiatric disorders
- 2. Body Mass Index (BMI) > 40
Show all 10Show fewer
- 3. Life expectancy < 1 year
- 4. Ongoing pregnancy
- 5. Patient under guardianship or curatorship
- 6. Patient already implanted with a spinal cord stimulation device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital de la Timone
Marseille
François CREMIEUX, +33491382001, francois.cremieux@ap-hm.fr
About this study
Official title: Efficacy of Posterior Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathic Pain: A Multicenter Randomized Crossover Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and debilitating side effect of many cancer treatments. It affects 28 to 48% of patients receiving chemotherapy. Symptoms include tingling, numbness, burning sensations, and pain mainly in the hands and feet. While CIPN often improves after chemotherapy ends, in some patients the pain persists and becomes chronic, severely impairing quality of life, sleep, and daily functioning.
Currently, no treatment has been shown to prevent CIPN. For patients with chronic pain, duloxetine is the only recommended drug, but its efficacy is limited. When standard medications fail, patients have very few options.
Read more
Spinal cord stimulation (SCS) is a well-established neurosurgical technique used to treat various forms of chronic neuropathic pain, including pain after surgery, trauma, or diabetes. In this procedure, thin electrodes are placed in the epidural space near the spinal cord and connected to a small implantable pulse generator. The electrical impulses delivered by the device modulate pain signals in the nervous system.
Preliminary case reports suggest that SCS may be effective in patients with CIPN, but no randomized controlled trial has yet established its value in this specific indication. The CHEMOSTIM study aims to fill this gap.
CHEMOSTIM is a multicenter, prospective, randomized crossover trial. All enrolled patients will undergo SCS implantation. Participants will then be randomized to receive either active stimulation first followed by sham stimulation, or sham stimulation first followed by active stimulation. In the sham phase, the device is implanted but switched off following a simulated programming session, so patients cannot tell which phase they are in.
The primary outcome is the proportion of patients achieving more than 50% pain reduction on a Visual Analog Scale (VAS) during the active stimulation phase compared to the sham stimulation phase, assessed at 4 months.
Secondary outcomes include changes in quality of life, anxiety and depression, sleep quality, medication use, individualized goal attainment, neurological examination, and nerve conduction studies. The study will also evaluate post-stimulation effects and complications.
Eligible patients are adults with chronic CIPN evolving for at least one year, with pain greater than 5/10 in the lower limbs, who have failed at least two lines of pharmacological treatment (antidepressants, anticonvulsants, topical agents, etc.) and whose indication for SCS has been validated by a multidisciplinary team following SFETD/SFNM guidelines.
- Being tested
- Spinal cord stimulation (FAST mode), Sham Spinal Cord Stimulation
- Keywords
- spinal cord stimulation, posterior cord stimulation, neuropathic pain, Chemotherapy-induced neuropathy
- Medical subject headings
- Neuralgia, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation (FAST mode)Device
Sub-perception spinal cord stimulation delivered in FAST mode at 10% below perception threshold. The remote control is sealed and given to the patient with instructions not to use it.
Sham Spinal Cord StimulationDevice
The implanted device is switched off following a simulated programming session identical to the active phase (perception threshold verified, stimulation reduced to 80% of threshold, then switched off). Patients are unable to distinguish sham from active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation first - Sham stimulation second | Experimental | Participants receive active spinal cord stimulation (FAST mode, sub-perception) for 4 months, followed by sham stimulation (device switched off) for 3 months. Receives: Device: Spinal cord stimulation (FAST mode) |
| Sham stimulation first → Active stimulation second | Sham comparator | Participants receive sham stimulation (device switched off) for 3 months, followed by active spinal cord stimulation (FAST mode, sub-perception) for 4 months. Receives: Device: Sham Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ≥50% pain reduction on Visual Analog Scale (VAS)
Measured: 4 months (end of first stimulation sequence)
Secondary outcomes (6)
Global Impression of Change
Measured: 4 months and 7 months
Anxiety and Depression (HADS)
Measured: 4 months and 7 months
Sleep Quality (Pittsburgh Sleep Quality Index)
Measured: 4 months and 7 months
Medication consumption
Measured: 4 months and 7 months
Goal Attainment Scale (GAS)
Measured: 4 months and 7 months
Device and stimulation-related complications
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579611
- Sponsor's protocol ID
- RCAPHM26_0012_CHEMOSTIM
- Acronym
- CHEMOSTIM
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Posterior Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathic Pain: A Multicenter Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07579611
- Acronym / sponsor ID
- CHEMOSTIM / RCAPHM26_0012_CHEMOSTIM
- Keywords
- spinal cord stimulation, posterior cord stimulation, neuropathic pain, Chemotherapy-induced neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- 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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and debilitating side effect of many cancer treatments. It affects 28 to 48% of patients receiving chemotherapy. Symptoms include tingling, numbness, burning sensations, and pain mainly in the hands and feet. While CIPN often improves after chemotherapy ends, in some patients the pain persists and becomes chronic, severely impairing quality of life, sleep, and daily functioning.
Currently, no treatment has been shown to prevent CIPN. For patients with chronic pain, duloxetine is the only recommended drug, but its efficacy is limited. When standard medications fail, patients have very few options.
Spinal cord stimulation (SCS) is a well-established neurosurgical technique used to treat various forms of chronic neuropathic pain, including pain after surgery, trauma, or diabetes. In this procedure, thin electrodes are placed in the epidural space near the spinal cord and connected to a small implantable pulse generator. The electrical impulses delivered by the device modulate pain signals in the nervous system.
Preliminary case reports suggest that SCS may be effective in patients with CIPN, but no randomized controlled trial has yet established its value in this specific indication. The CHEMOSTIM study aims to fill this gap.
CHEMOSTIM is a multicenter, prospective, randomized crossover trial. All enrolled patients will undergo SCS implantation. Participants will then be randomized to receive either active stimulation first followed by sham stimulation, or sham stimulation first followed by active stimulation. In the sham phase, the device is implanted but switched off following a simulated programming session, so patients cannot tell which phase they are in.
The primary outcome is the proportion of patients achieving more than 50% pain reduction on a Visual Analog Scale (VAS) during the active stimulation phase compared to the sham stimulation phase, assessed at 4 months.
Secondary outcomes include changes in quality of life, anxiety and depression, sleep quality, medication use, individualized goal attainment, neurological examination, and nerve conduction studies. The study will also evaluate post-stimulation effects and complications.
Eligible patients are adults with chronic CIPN evolving for at least one year, with pain greater than 5/10 in the lower limbs, who have failed at least two lines of pharmacological treatment (antidepressants, anticonvulsants, topical agents, etc.) and whose indication for SCS has been validated by a multidisciplinary team following SFETD/SFNM guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation first - Sham stimulation second | Experimental | Device: Spinal cord stimulation (FAST mode)Participants receive active spinal cord stimulation (FAST mode, sub-perception) for 4 months, followed by sham stimulation (device switched off) for 3 months. |
| Sham stimulation first → Active stimulation second | Sham comparator | Device: Sham Spinal Cord StimulationParticipants receive sham stimulation (device switched off) for 3 months, followed by active spinal cord stimulation (FAST mode, sub-perception) for 4 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient with chemotherapy-induced painful neuropathy (platinum salts, vincristine, taxanes, alkaloids, epothilone, thalidomide, etc.) evolving for at least 1 year
- Indication for spinal cord stimulation validated by a multidisciplinary team meeting according to SFETD/SFNM guidelines
- Resistance to pharmacological or topical treatment (failure of at least two therapeutic lines or intolerable side effects: anticonvulsants, antidepressants, capsaicin, etc.)
- Pain score > 5/10 on numerical scale in the lower limbs
- Patient able to understand and give informed consent to the protocol
Key exclusion criteria (10 listed)
- 1. Contraindication to spinal cord stimulation:
- Extensive laminectomy
- Coagulopathy
- Intercurrent infections
- Psychiatric disorders
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 |
|---|---|---|
| Spinal cord stimulation (FAST mode)Sub-perception spinal cord stimulation delivered in FAST mode at 10% below perception threshold. The remote control is sealed and given to the patient with instructions not to use it. | Device | Active stimulation first - Sham stimulation second |
| Sham Spinal Cord StimulationThe implanted device is switched off following a simulated programming session identical to the active phase (perception threshold verified, stimulation reduced to 80% of threshold, then switched off). Patients are unable to distinguish sham from active stimulation. | Device | Sham stimulation first → Active stimulation second |
Primary outcome
Proportion of patients with ≥50% pain reduction on Visual Analog Scale (VAS)
Time frame: 4 months (end of first stimulation sequence)
6 secondary outcomes
Global Impression of Change
Time frame: 4 months and 7 months
Anxiety and Depression (HADS)
Time frame: 4 months and 7 months
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: 4 months and 7 months
Medication consumption
Time frame: 4 months and 7 months
Goal Attainment Scale (GAS)
Time frame: 4 months and 7 months
Device and stimulation-related complications
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation (FAST mode) in people with Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Assistance Publique Hopitaux De Marseille 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne MD PHD BALOSSIER (+33491384277, anne.balossier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with ≥50% pain reduction on Visual Analog Scale (VAS) (time frame: 4 months (end of first stimulation sequence)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.