Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Photobiomodulation: Patients will receive 20 Joule/cm2

Study summary

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. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. 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. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.

Eligibility

Primary outcome measure(s)

• severity of CIPN measured by modified Total Neurpathy Score m-TNS — At baseline (week 0) and at week 3 and week 6
  Include several simple neurological tests

Trial sites (1)

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