Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy

Sponsor
Assistance Publique Hopitaux De Marseille
Study ID
NCT07579611
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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