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

Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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 Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marithé Claes, MSc; Phone Number: +32 011 33 72 39; Email: marithe.claes@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.
Experimental: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified total neuropathy score (mTNS)	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.	Baseline
Modified total neuropathy score (mTNS)	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.	Three weeks post-PBM
Pain score	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.	Baseline
Pain score	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.	Three weeks post-PBM
Mobility score	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.	Baseline
Mobility score	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.	Three weeks post-PBM
Modified total neuropathy score (mTNS)	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.	End of PBM (six weeks post-baseline)
Pain score	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.	End of PBM (six weeks post-baseline)
Mobility score	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.	End of PBM (six weeks post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	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.	Baseline
Quality of life score	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.	Three weeks post-PBM
Satisfaction score	The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).	Baseline
Quality of life score	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.	End of PBM (six weeks post-baseline)
Satisfaction score	The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).	End of PBM (six weeks post-baseline)
satisfaction score	The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).	Three weeks post-PBM

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	Baseline
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	Three weeks post-PBM
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	One year post chemotherapy
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	End of PBM (six weeks post-baseline)
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Two year post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Three year post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Four year post chemotherapy
Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Five year post chemotherapy

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Anticipated): March 15, 2025
• Study Completion (Anticipated): March 15, 2030

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Photobiomodulation therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2023/007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No