Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy (NeuroLight 2)

Jessa Hospital

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05763706

2023/007

Details and patient eligibility

About

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.

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

172 participants in 2 patient groups

Experimental: PBM1 group

Experimental group

Description:

The patients allocated to the first PBM-group will receive twelve PBM sessions of 6 J/cm² over six weeks (2x/week).

Treatment:

Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

Experimental: PBM2 group

Experimental group

Description:

The patients allocated to the second PBM-group will receive twelve PBM sessions of 8 J/cm² over six weeks (2x/week).

Treatment:

Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)