Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy (CHEMOSTIM)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy (CIPN); Cancer-related Pain
• Intervention / Treatment: Device: Spinal cord stimulation (FAST mode); Device: Sham Spinal Cord Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne MD PHD BALOSSIER; Phone Number: +33491384277; Email: anne.balossier@ap-hm.fr

Study Locations

• France
  • Marseille, France
    • Hopital de la Timone
    • Contact: François CREMIEUX; Phone Number: +33491382001; Email: francois.cremieux@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patient with chemotherapy-induced painful neuropathy (platinum salts, vincristine, taxanes, alkaloids, epothilone, thalidomide, etc.) evolving for at least 1 year
2. Indication for spinal cord stimulation validated by a multidisciplinary team meeting according to SFETD/SFNM guidelines
3. Resistance to pharmacological or topical treatment (failure of at least two therapeutic lines or intolerable side effects: anticonvulsants, antidepressants, capsaicin, etc.)
4. Pain score > 5/10 on numerical scale in the lower limbs
5. Patient able to understand and give informed consent to the protocol
6. Patient affiliated to the French Social Security system
7. Patient able to complete follow-up questionnaires

Exclusion Criteria:

• 1. Contraindication to spinal cord stimulation:
• Extensive laminectomy
• Coagulopathy
• Intercurrent infections

• Psychiatric disorders

  2. Body Mass Index (BMI) > 40

  3. Life expectancy < 1 year

  4. Ongoing pregnancy

  5. Patient under guardianship or curatorship

  6. Patient already implanted with a spinal cord stimulation device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active stimulation first - Sham stimulation second; 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); 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 Comparator: Sham stimulation first → Active stimulation second; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with ≥50% pain reduction on Visual Analog Scale (VAS)	4 months (end of first stimulation sequence)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Device and stimulation-related complications	7 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neuropathic pain; spinal cord stimulation; Chemotherapy-induced neuropathy; posterior cord stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain; Neuralgia; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Spinal Cord Stimulation
• Other Study ID Numbers: RCAPHM26_0012_CHEMOSTIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No