Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

Pilot randomised sham-controlled trial of electroacupuncture at onset of chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer. (#504)

Victoria Choi 1 2 , Susanna Park 1 , Judith Lacey 2 3 , Sanjeev Kumar 2 4 5 , Gillian Heller 2 6 , Peter Grimison 2 6
  1. Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
  2. Chris O'Brien Lifehouse, Camperdown, 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

Aims

CIPN is a frequent dose-limiting side effect of neurotoxic chemotherapy. Currently, there are no effective treatments, and the usual management relies on dose reduction/and or cessation. The primary aim of this pilot trial is to determine the feasibility and acceptability of electroacupuncture (EA) commencing at onset of CIPN during taxane treatment in a randomised controlled setting, with a secondary aim to compare deterioration of CIPN symptoms during and after taxane treatment amongst participants allocated to EA or sham-EA.

 

Methods

This is a single centre, randomised, sham-controlled, parallel group pilot phase II trial with two arms (EA and sham-EA), with a 1:1 allocation ratio. Sample size n=40 (20 per arm) is proposed based on detection of a very large effect, assuming equal numbers in EA and sham-EA groups, with 80% power at a two-sided significance level of 5%. Participants will be screened weekly for CIPN symptoms using a validated patient reported outcome measure prior to their taxol infusion (up to cycle 6) and randomised to either treatment arm only if symptomatic. Participants in both groups will receive either EA or sham-EA for 10 consecutive weeks, with a follow-up period of 8 and 24 weeks. Primary outcome measure of CIPN will be assessed using the EORTC QLQ-CIPN20.

 

Statistical considerations

To evaluate the effect of EA compared to sham-EA, baseline measure of EORTC QLQ-CIPN20 overall scores at onset of CIPN will be compared to end of treatment scores using a nonparametric test (Mann-Whitney) on the change scores.

 

Study progress

At August 2023, 27 of 40 patients have been recruited and randomised to a treatment arm. This work is supported by the Chris O’Brien Lifehouse Surfebruary Cancer Research Fund.