Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA)

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT07575750
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active taVNS (TENS ECO Plus) — DEVICE
    Active taVNS delivered through a transcutaneous auricular vagus nerve stimulation device applied to the left ear. The device provides active electrical stimulation according to predefined stimulation parameters. Participants perform daily home stimulation sessions for the duration of the study.
  • Sham taVNS (TENS ECO Plus) — DEVICE
    Sham taVNS delivered through a device identical in appearance and display to the active device but delivering no active electrical stimulation. Participants perform daily home sessions following the same schedule as the active group.

Study Details

Breast cancer (BCa) is the most common cancer in women. The majority of BCa are hormone receptor positive and substantial benefits have been demonstrated for adjuvant endocrine therapies in reducing recurrence and extending survival in women. Aromatase inhibitors (AI) are commonly prescribed for women diagnosed with hormone receptor positive BCa. In parallel with this improvement in survival, women may experience a frequent adverse effect from AI therapy with arthralgia, or joint pain and stiffness. AI-induced arthralgia (AIA) is experienced by about 50 % of recipients. The main AIA symptoms are joint pain and stiffness, mainly in the hands, wrists, and knees, symmetrically. Although AIA can occur at any time after initiating AI, the median time to onset is approximately 6 weeks with peak symptoms at 6 months. Additionally, AIA impairs quality of life (QoL) and pain severity is associated with premature discontinuation and non-adherence to AI therapy which in turn is significantly associated with increased mortality in BCa patients. Declining levels of oestrogen induced by AI results in increased production of proinflammatory cytokines hitting chondrocytes resulting in joint pain and swelling. The autonomic nervous system (ANS) plays an important role in the regulation of inflammation. Dysregulation of the ANS is observed in women treated for BCa. Acupuncture, exercise, duloxetine, … have potential to improve AIA in BCa survivors, however, few studies have attempted to compare different modalities, resulting in a lack of evidence-based decision making for these interventions. A novel, non-invasive, wearable vagus nerve stimulation device has been created and has the potential to modulate proinflammatory cytokine production and reduce inflammation by affecting the functioning of the autonomic nervous system. Some studies have demonstrated the safety and efficacy of this device after several weeks of treatment, on the intensity of pain secondary to rheumatic diseases after several weeks of treatment. We would like to study the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) for patients with aromatase inhibitor-induced arthralgia

Key Dates

First listed
May 8, 2026
Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental arm: active device
    Participants assigned to the active taVNS arm received a transcutaneous auricular vagus nerve stimulation device delivering active electrical stimulation to the left auricular branch of the vagus nerve. Stimulation intensity was progressively adjusted in 1-mA increments until the participant reported a slight pricking or tingling sensation or reached the maximum intensity. Daily stimulation sessions were performed at home according to the study schedule
  • Sham Comparator: Control arm : sham device
    Participants assigned to the sham taVNS arm received an identical device with the same appearance and display as the active device but delivering no active electrical stimulation. Stimulation intensity was simulated without producing perceptible electrical output, maintaining blinding of participants and staff. Daily home sessions followed the same schedule and instructions as in the active arm

Primary Outcome Measure

Proportion of Participants Achieving ≥30% Reduction in Average Pain Intensity (BPI-AP) From Baseline at 6 Weeks [ Time Frame: 6 weeks ]

Central Contacts

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