Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

• Registration Number: NCT05763706
• Lead Sponsor: Jessa Hospital

Brief 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.

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Study First Posted: 2023-03-10
• Study Start: 2023-03-27
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30
• Primary Completion: 2025-03-15
• Study Completion: 2030-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: PBM1 group	Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)	The patients allocated to the first PBM-group will receive twelve PBM sessions of 6 J/cm² over six weeks (2x/week).
Experimental: PBM2 group	Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)	The patients allocated to the second PBM-group will receive twelve PBM sessions of 8 J/cm² over six weeks (2x/week).

Primary Outcome Measures

Name	Time	Method
Pain score	Three weeks post-PBM	The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain.
Modified total neuropathy score (mTNS)	Three weeks post-PBM	The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy.
Mobility score	Three weeks post-PBM	The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI.

Secondary Outcome Measures

Name	Time	Method
Quality of life score	Three weeks post-PBM	The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life.
Satisfaction score	End of PBM (six weeks post-baseline)	The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).
satisfaction score	Three weeks post-PBM	The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium