The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial)

Abstract

Purpose: The purpose of this study was to investigate the effectiveness of photobiomodulation (PBM) therapy for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients.

Methods: A prospective, randomized placebo-controlled pilot trial (NEUROLASER) was set up with 32 breast cancer patients who underwent chemotherapy (ClinicalTrials.gov; NCT03391271). Patients were randomized to receive PBM (n = 16) or placebo treatments (n = 16) (2 × /week) during their chemotherapy. The modified Total Neuropathy Score (mTNS), six-minute walk test (6MWT), Numeric pain Rating Scale (NRS), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Taxane (FACT/GOG-Taxane) were used to evaluate the severity of CIPN and the patients' quality of life (QoL). Outcome measures were collected at the first chemotherapy session, 6 weeks after initiation of chemotherapy, at the final chemotherapy session, and 3 weeks after the end of chemotherapy (follow-up).

Results: The mTNS score increased significantly over time in both the control and the PBM group. A significantly higher score for FACT/GOG-Taxane was observed in the PBM group during chemotherapy compared to the control group. Questions of the FACT/GOG-Taxane related to sensory peripheral neuropathy symptoms showed a significant increase in severeness over time in the control group, whereas they remained constant in the PBM group. At follow-up, a (borderline) significant difference was observed between both groups for the 6MWT and patients' pain level, in benefit of the PBM group.

Conclusions: This NEUROLASER trial shows promising results concerning the prevention of CIPN with PBM in breast cancer patients. Furthermore, a better QoL was observed when treated with PBM.

Keywords: Breast cancer; Chemotherapy; Peripheral neuropathy; Photobiomodulation; Polyneuropathy.

Fig. 1

Flowchart. PBM, photobiomodulation; CT, chemotherapy

Fig. 2

Modified Total Neuropathy Score (mTNS). Comparison of mTNS between the control group (n = 16) and the PBM group (n = 16) over time. Data are presented as median ± interquartile range. A higher score indicates a more severe grade of peripheral neuropathy. For both groups, a significant increase of mTNS was observed (Ps < 0.001) using the Friedman test. PBM, photobiomodulation; CT, chemotherapy

Fig. 3

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Taxane (FACT/GOG-Taxane) total score. Comparison of FACT/GOG-Taxane total score between the control group (n = 15) and the PBM group (n = 16) over time. Data are shown as means and a higher score indicates a better quality of life (QoL). Mixed ANOVA revealed significant main time effect, and time by group interaction (Ps < 0.036). No significant main group effect was observed (P = 0.067). PBM, photobiomodulation; CT, chemotherapy

Fig. 4

Six-minute walk test (6MWT). Comparison of percent predicted 6MWT distance between the control group (n = 16) and the PBM group (n = 16) at different time points. Data are presented as median ± interquartile range. A significant difference at follow-up between the control group and the PBM group was observed using the Mann–Whitney U test, two-tailed (P = 0.035) PBM, photobiomodulation; CT, chemotherapy