Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT05763706

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2030-03-15

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: PBM1 group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.

Experimental: PBM2 group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.

Interventions

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

MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen mebis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Jessa Hospital

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jeroen Mebis, Prof. Dr.

Role: CONTACT

jeroen.mebis@jessazh.be

011 33 72 21 ext. +32

Marithé Claes, MSc

Role: CONTACT

marithe.claes@uhasselt.be

011 33 72 39 ext. +32

Facility Contacts

Jeroen Mebis, Prof. Dr.

Role: primary

jeroen.mebis@jessazh.be

+32 11 33 72 21

Marithé Claes, MSc

Role: backup

marithe.claes@uhasselt.be

+32 11 33 72 39

Other Identifiers

2023/007

Identifier Type: -

Identifier Source: org_study_id