Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy

Last updated: March 28, 2023
Sponsor: Jessa Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT05763706
2023/007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 mightinterfere with study participation (e.g., dementia or psychosis)
  • Dutch-speaking
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Taking stable doses of medication on prescription for peripheral neuropathy. Relatedmedications 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 Fitzpatrickscale)

Study Design

Total Participants: 172
Study Start date:
March 27, 2023
Estimated Completion Date:
March 15, 2030

Study 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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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.

Connect with a study center

  • Jessa Hospital

    Hasselt, Limburg 3500
    Belgium

    Active - Recruiting

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