Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity that poses a major clinical challenge when managing patients receiving specific chemotherapy regimens (e.g. taxanes and Bortezomib). There is a growing body of literature that suggests acupuncture can lead to improvements in CIPN symptoms.
Objective: To evaluate the effectiveness of acupuncture as a management tool for CIPN by comparing use of acupuncture with standard care (Acupuncture) against standard care alone (Control), to reduce symptoms of CIPN.
Methods: This two-site clinical trial used a phase II, randomised, parallel group design to investigate the effectiveness of a 10-week course of acupuncture. Patients experiencing CIPN of ≥ Grade II (CTCAE v4.03), recording a ‘Most Troublesome’ CIPN symptom score of ≥ 3 using the "Measure Yourself Medical Outcome Profile" (MYMOP 2), were randomised (1:1) to ‘Acupuncture’ or ‘Control’ (note: Patients in Control were offered acupuncture off trial at the end of their study period). Primary endpoint was a ≥ 2-point improvement (success) in MYMOP2 score at week 10. 100 participants (120 randomised to allow for attrition) were required (90% power; 10% one-sided alpha) for a hypothesised improvement in success proportions from 30% to 55% using a primary analysis model with logistic regression adjusted for stratification factors and baseline MYMOP2 scores.
Results: Primary MYMOP2 outcome data at week 10 was available for 108 of 120 randomised participants. There were 36/53 (68%) successes in ‘Acupuncture’ compared to 18/55 (33%) in ‘Control’. The adjusted success odds ratio was 4.3 (95% CI 1.9 to 9.6; 2p < 0.001; Acupuncture vs Control). Beneficial effects were also seen in the secondary outcome data, including clinicians’ grading of neuropathy, EORTC QLQ-CIPN20, QLQ-C30 summary scores and patient reported pain scores.
Conclusion: A 10-week course of acupuncture resulted in measureable improvement in participants symptoms of CIPN. The results warrant further investigation within a phase III trial.
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