Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Pilot Trial (NeuroLight)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2028
  • participants needed
    60
  • sponsor
    Jessa Hospital
Updated on 15 October 2022

Summary

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.

Description

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.

Details
Condition Chemotherapy-induced Peripheral Neuropathy
Treatment Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
Clinical Study IdentifierNCT05199389
SponsorJessa Hospital
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib
Diagnosed with CIPN
Age 18 years or above
Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
Dutch-speaking
Signed informed consent

Exclusion Criteria

Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine
Severe or unstable cardio- respiratory or musculoskeletal disease
Interruption of more than two consecutive laser treatments
Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
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