Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy

NCT07579611 | Not Yet Recruiting DMC

• 1 other identifier: RCAPHM26_0012_CHEMOSTIM
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy (CIPN); Cancer-related Pain

Keywords

spinal cord stimulation; posterior cord stimulation; neuropathic pain; Chemotherapy-induced neuropathy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with ≥50% pain reduction on Visual Analog Scale (VAS)

  4 months (end of first stimulation sequence)

Secondary Outcomes (6)

• Global Impression of Change

  4 months and 7 months

• Anxiety and Depression (HADS)

  4 months and 7 months

• Sleep Quality (Pittsburgh Sleep Quality Index)

  4 months and 7 months

• Medication consumption

  4 months and 7 months

• Goal Attainment Scale (GAS)

  4 months and 7 months

Study Arms (2)

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.

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.

Device: Sham Spinal Cord Stimulation

Interventions

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.

Active stimulation first - Sham stimulation second

Sham Spinal Cord Stimulation DEVICE

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.

Sham stimulation first → Active stimulation second

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Contraindication to spinal cord stimulation:
• Extensive laminectomy
• Coagulopathy
• Intercurrent infections
• Psychiatric disorders
• \. Body Mass Index (BMI) \> 40
• \. Life expectancy \< 1 year
• \. Ongoing pregnancy
• \. Patient under guardianship or curatorship
• \. Patient already implanted with a spinal cord stimulation device

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital de la Timone

Marseille, France

Location

MeSH Terms

Conditions

Neuralgia; Cancer Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Anne MD PHD BALOSSIER

CONTACT

+33491384277; anne.balossier@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants are blinded to the stimulation sequence (active vs. sham). Blinding is maintained through a simulated programming session at the start of the sham phase, making it impossible for participants to determine whether stimulation is active or inactive. The surgeon and clinical team are not blinded. The outcome assessor performing pain and functional evaluations is blinded to the sequence allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)