Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— NeuroLight  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05199389
• Other study ID #: 2021/155
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: November 10, 2028

Study information

• Verified date: March 2024
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 10, 2028
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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 (three weeks post-baseline)
Other	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
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	One year post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Two years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Three years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Four years post chemotherapy
Other	Cancer relapse or recurrence	The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.	Five years post chemotherapy
Primary	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
Primary	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 (three weeks post-baseline)
Primary	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
Primary	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
Primary	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 (three weeks post-baseline)
Primary	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
Primary	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
Primary	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 (three weeks post-baseline)
Primary	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
Secondary	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
Secondary	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 (three weeks post-baseline)
Secondary	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
Secondary	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
Secondary	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 (three weeks post-baseline)
Secondary	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