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

Lodewijckx Joy, Robijns Jolien, Claes Marithé, Evens Stijn, Swinnen Laura, Lenders Hilde, Bortels Sandra, Nassen Wendy, Hilkens Ruth, Raymakers Liesbeth, Snoekx Sylvana, Hermans Sylvia, Mebis Jeroen, Lodewijckx Joy, Robijns Jolien, Claes Marithé, Evens Stijn, Swinnen Laura, Lenders Hilde, Bortels Sandra, Nassen Wendy, Hilkens Ruth, Raymakers Liesbeth, Snoekx Sylvana, Hermans Sylvia, Mebis Jeroen

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.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart. PBM, photobiomodulation; CT, chemotherapy
Fig. 2
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
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
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

References

    1. Addington, J. And M. Freimer, Chemotherapy-induced peripheral neuropathy: an update on the current understanding. F1000Res, 2016. 5.
    1. Hou S, et al. Treatment of chemotherapy-induced peripheral neuropathy: systematic review and recommendations. Pain Physician. 2018;21(6):571–592.
    1. Mols F, et al. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014;22(8):2261–2269.
    1. Song X, et al. Cost of peripheral neuropathy in patients receiving treatment for multiple myeloma: a US administrative claims analysis. Therapeutic advances in hematology. 2019;10:2040620719839025–2040620719839025.
    1. Pike CT, et al. (2012) Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer. Chemother Res Pract, 2012. 2012: p. 913848
    1. Argyriou AA, et al. Peripheral nerve damage associated with administration of taxanes in patients with cancer. Crit Rev Oncol Hematol. 2008;66(3):218–228.
    1. Seretny M, et al. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. Pain. 2014;155(12):2461–2470.
    1. Han Y, M.T. Smith, Pathobiology of cancer chemotherapy-induced peripheral neuropathy (CIPN) Front Pharmacol. 2013;4:156.
    1. Al-Massri KF, Ahmed LA, El-Abhar HS. Mesenchymal stem cells therapy enhances the efficacy of pregabalin and prevents its motor impairment in paclitaxel-induced neuropathy in rats: role of Notch1 receptor and JAK/STAT signaling pathway. Behav Brain Res. 2019;360:303–311.
    1. Kautio AL, et al. Amitriptyline in the treatment of chemotherapy-induced neuropathic symptoms. J Pain Symptom Manage. 2008;35(1):31–39.
    1. Rao RD, et al. Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer. 2008;112(12):2802–2808.
    1. Rao RD, et al. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3) Cancer. 2007;110(9):2110–2118.
    1. Loprinzi CL, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: ASCO Guideline Update. J Clin Oncol. 2020;38(28):3325–3348.
    1. De Freitas LF, Hamblin MR (2016) Proposed mechanisms of photobiomodulation or low-level light therapy. IEEE J Sel Top Quantum Electron 22(3)
    1. Zecha JA, et al. Low level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 1: mechanisms of action, dosimetric, and safety considerations. Support Care Cancer. 2016;24(6):2781–2792.
    1. Zecha JA, et al. Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. Support Care Cancer. 2016;24(6):2793–2805.
    1. Dompe C, et al. Photobiomodulation-underlying mechanism and clinical applications. J Clin Med. 2020;9(6):1724.
    1. Rochkind S. Photobiomodulation in neuroscience: a summary of personal experience. Photomed Laser Surg. 2017;35(11):604–615.
    1. Rochkind S. Phototherapy in peripheral nerve regeneration: from basic science to clinical study. Neurosurg Focus. 2009;26(2):E8.
    1. Anders JJ, et al. In vitro and in vivo optimization of infrared laser treatment for injured peripheral nerves. Lasers Surg Med. 2014;46(1):34–45.
    1. Cho H, et al. (2020) Neurite growth of trigeminal ganglion neurons in vitro with near-infrared light irradiation. J Photochem Photobiol B 210: p. 111959
    1. Khamseh ME, et al. Diabetic distal symmetric polyneuropathy: effect of low-intensity laser therapy. Lasers Med Sci. 2011;26(6):831–835.
    1. Bashiri H. Evaluation of low level laser therapy in reducing diabetic polyneuropathy related pain and sensorimotor disorders. Acta Med Iran. 2013;51(8):543–547.
    1. Yamany AA, Sayed HM. Effect of low level laser therapy on neurovascular function of diabetic peripheral neuropathy. J Adv Res. 2012;3(1):21–28.
    1. Kumar S, et al. Efficacy of low level laser therapy on painful diabetic peripheral neuropathy. Laser Therapy. 2015;24(3):195–200.
    1. Argenta PA, et al. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: a randomized, sham-controlled clinical trial. Gynecol Oncol. 2017;144(1):159–166.
    1. Hsieh YL, et al. Laser acupuncture attenuates oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: a pilot prospective cohort study. Acupunct Med. 2016;34(5):398–405.
    1. Hsieh YL, Fan YC, Yang CC. Low-level laser therapy alleviates mechanical and cold allodynia induced by oxaliplatin administration in rats. Support Care Cancer. 2016;24(1):233–242.
    1. Lodewijckx J, et al. Photobiomodulation therapy for the management of chemotherapy-induced peripheral neuropathy: an overview. Photobiomodul Photomed Laser Surg. 2020;38(6):348–354.
    1. Vasquez S, et al. Chemotherapy induced peripheral neuropathy: the modified total neuropathy score in clinical practice. Ir J Med Sci. 2014;183(1):53–58.
    1. Fisher MI, et al. Oncology section EDGE task force on breast cancer outcomes: a systematic review of outcome measures for functional mobility. Rehabilitation Oncology. 2015;33(3):19–31.
    1. Hile E, et al. Oncology section task force on breast cancer outcomes: clinical measures of chemotherapy-induced peripheral neuropathy—a systematic review. Rehabilitation Oncology. 2015;33(3):32–41.
    1. Alberti P. Chemotherapy-induced peripheral neurotoxicity - outcome measures: the issue. Expert Opin Drug Metab Toxicol. 2017;13(3):241–243.
    1. Brewer JR, et al. Chemotherapy-induced peripheral neuropathy: current status and progress. Gynecol Oncol. 2016;140(1):176–183.
    1. Cavaletti G, et al. Chemotherapy-induced peripheral neurotoxicity assessment: a critical revision of the currently available tools. Eur J Cancer. 2010;46(3):479–494.
    1. Park SB, et al. Overview and critical revision of clinical assessment tools in chemotherapy-induced peripheral neurotoxicity. J Peripher Nerv Syst. 2019;24(Suppl 2):S13–s25.
    1. Gordon-Williams R, Farquhar-Smith P (2020) Recent advances in understanding chemotherapy-induced peripheral neuropathy. F1000Res, 9
    1. Bensadoun RJ, et al. Safety and efficacy of photobiomodulation therapy in oncology: a systematic review. Cancer Med. 2020;9(22):8279–8300.
    1. Wikramanayake TC, et al. Low-level laser treatment accelerated hair regrowth in a rat model of chemotherapy-induced alopecia (CIA) Lasers Med Sci. 2013;28(3):701–706.
    1. Morais MO, et al. A prospective study on oral adverse effects in head and neck cancer patients submitted to a preventive oral care protocol. Support Care Cancer. 2020;28(9):4263–4273.
    1. Genot-Klastersky MT, et al. Retrospective evaluation of the safety of low-level laser therapy/photobiomodulation in patients with head/neck cancer. Support Care Cancer. 2020;28(7):3015–3022.
    1. Brandao TB, et al. Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. Support Care Cancer. 2018;26(7):2417–2423.
    1. Marín-Conde F, et al. Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. Int J Oral Maxillofac Surg. 2019;48(7):917–923.
    1. Antunes HS, et al. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017;71:11–15.
    1. Bezinelli LM, et al. Long-term safety of photobiomodulation therapy for oral mucositis in hematopoietic cell transplantation patients: a 15-year retrospective study. Support Care Cancer. 2021;29(11):6891–6902.
    1. Şimşek NY, Demir A. Cold application and exercise on development of peripheral neuropathy during taxane chemotherapy in breast cancer patients: a randomized controlled trial. Asia Pac J Oncol Nurs. 2021;8(3):255–266.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj