Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2024

Pilot sham-controlled randomised trial of electroacupuncture for chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving taxanes for early breast cancer (#520)

Victoria Choi 1 2 , Susanna B Park 2 , Judith Lacey 1 3 , Sanjeev Kumar 1 4 5 , Gillian Heller 1 6 , Peter Grimison 1 6
  1. Chris O'Brien Lifehouse, Camperdown, NSW, Australia
  2. Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
  3. Clinical School of Medicine, University of Sydney, Sydney, NSW, Australia
  4. School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia
  5. Garvan Institute of Medical Research, Sydney, NSW, Australia
  6. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting toxicity of taxanes with limited effective treatments. Electroacupuncture (EA) is an Integrative Oncology treatment that could ameliorate CIPN. This single-centre, pilot, sham-controlled randomised, phase II trial aimed to assess the feasibility, acceptability, and preliminary signal of activity of early EA intervention during taxanes.

Methods

Eligible patients with stage I-III breast cancer receiving weekly or 3-weekly taxanes were randomised 1:1 at CIPN onset to receive EA or sham-EA once weekly for 10 weeks, with follow-up at 8- and 24-weeks post-taxanes. Primary outcomes were feasibility and acceptability measured by recruitment, adherence rates, patient blinding success, and follow-up compliance. Secondary outcomes included the extent of deterioration of CIPN in each group from randomisation to week 12 of chemotherapy assessed by the EORTC QLQ-CIPN20 (linearly converted into a 0-100 scale), compared using the Mann-Whitney test; and the proportion of patients completing 12 weeks of chemotherapy without CIPN-related dose modifications.

Results

34 patients were randomised into EA or Sham-EA groups (n=17 each). Completion rates for the 10-week intervention were 82.0% (EA) vs. 94.0% (Sham-EA). Follow-up compliance was 82.0% (EA) vs. 76.0% (Sham-EA) at 8 weeks, and 82.0% (EA) vs. 71.0% (Sham-EA) at 24 weeks. The recruitment rate averaged 3.7 patients per month. More patients correctly identified their treatment group in EA (63.0%) than Sham-EA groups (35.0%). 82.0% of patients in both groups did not require CIPN-related taxane dose modifications. This study was not powered to detect efficacy and did not demonstrate a statistically significant difference in CIPN deterioration scores between groups: EA 5.4 (SD 8.2), Sham-EA 3.3 (SD 10.3), P= 0.48.

Conclusions

The pilot study demonstrated high feasibility and acceptability with adequate blinding. A larger randomised controlled trial is needed to determine the efficacy of EA.