LBA4 - A randomized controlled trial to relieve distress of chemotherapy-induced peripheral neuropathy by magnetic field: SMILE study

Background

Few effective treatments for painful chemotherapy-induced peripheral neuropathy (CIPN) exist apart from duloxetine. AT-04 is a newly developed portable magnetic field irradiation device. This trial aimed to examine the safety and efficacy of AT-04 for patients with CIPN.

Methods

This was a multicenter, randomized, sham device-controlled, double-blind study. Patients were eligible if they had CIPN symptoms with a pain Numeric Rating Scale (NRS) of 4/10 or more during the 2 weeks before registration, at least 12 weeks had passed since the last administration of paclitaxel for breast cancer or oxaliplatin for colorectal cancer as perioperative chemotherapy, and there was no recurrence. AT-04, or sham device, was used for 12 weeks. The primary endpoint was the change in pain NRS at 12 weeks compared with the baseline. Secondary endpoints were tingling NRS, numbness NRS, and treatment-related adverse events (trAEs) measured by CTCAE. The planned sample size was 28 to detect 0.75 decrease for the primary endpoint, with standard deviation of 1.0, one-sided alpha of 0.15 and power of 80%.

Results

Fourteen patients were accrued in both arms. No significant differences were observed in the primary endpoint (-1.74 ± 0.6 in AT-04 vs. -1.45 ± 0.6 in sham; one-sided p = 0.36, effect size = 0.48). Similarly, there were no significant differences in the changes in tingling NRS (-1.42 ± 1.8 vs. -1.73 ± 2.0; p = 0.69, effect size = 0.16) or numbness NRS (-1.50 ± 1.9 vs. -0.36 ± 1.9; p = 0.17, effect size = 0.60) after 12 weeks. Among patients whose last chemotherapy occurred more than one year prior, the mean changes in pain NRS (-1.25 ± 1.7 in AT-04 vs. -0.50 ± 2.4 in sham; p = 0.48, effect size = 0.36), tingling NRS (-2.00 ± 1.7 vs. -0.75 ± 1.0; p = 0.10, effect size = 0.9), and numbness NRS (-1.50 ± 1.8 vs. 0 ± 1.9; p = 0.12, effect size = 0.81) showed similar trends. The trAEs were 0 in the AT-04 group and 2 in the sham group.

Conclusions

This exploratory trial indicated that AT-04 did not significantly reduce pain, tingling, or numbness after 12 weeks in patients with CIPN. However, notable effect sizes were observed in tingling and numbness among patients whose last chemotherapy was over a year ago.

Clinical trial identification

jRCT2032220295.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Japan Agency for Medical Research and Development, and Peace of Mind Co., Ltd.

Disclosure

I. Kishita: Financial Interests, Personal, Member of Board of Directors: Peace of Mind Co., Ltd. T. Miura: Financial Interests, Personal, Stocks/Shares: Peace of Mind Co., Ltd. All other authors have declared no conflicts of interest.