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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
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 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.
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Proportion of Participants Achieving ≥30% Reduction in Average Pain Intensity (BPI-AP) From Baseline at 6 Weeks
The primary endpoint is the proportion of participants who achieve a ≥30% reduction from baseline in the Brief Pain Inventory - Average Pain (BPI-AP) score. The BPI-AP corresponds to the participant's average pain intensity over the past 7 days. Baseline is defined as the BPI-AP score collected before initiation of the 6-week taVNS intervention. Effectiveness of taVNS will be evaluated by comparing the response rate (≥30% pain reduction) at Week 6 with baseline values.
Time frame: 6 weeks
Proportion of Participants Achieving ≥30% Reduction in Average Pain Intensity (BPI-AP) From Baseline at 3 months
The primary endpoint is the proportion of participants who achieve a ≥30% reduction from baseline in the Brief Pain Inventory - Average Pain (BPI-AP) score. The BPI-AP corresponds to the participant's average pain intensity over the past 7 days. Baseline is defined as the BPI-AP score collected before initiation of the 6-week taVNS intervention. Effectiveness of taVNS will be evaluated by comparing the response rate (≥30% pain reduction) at 3 months with baseline values
Time frame: 3 months
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