Chemotherapy-induced Peripheral NeuropathyNeuroLightNCT05199389
Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy
A study testing Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) in people with Chemotherapy-induced Peripheral Neuropathy, run by Jessa Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2022to 10 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Pilot 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.
Read the 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.
- Being tested
- Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
- Keywords
- Photobiomodulation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)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.
| Study group | Role | What they receive |
|---|---|---|
| PBM1 group | Experimental | The patients allocated to the first PBM-group will receive six PBM sessions of 6 J/cm² over three weeks (2x/week). Receives: Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) |
| PBM2 group | Experimental | The patients allocated to the first PBM-group will receive six PBM sessions of 8 J/cm² over three weeks (2x/week). Receives: Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: End of PBM (three weeks post-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.
Measured: 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.
Measured: 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.
Measured: End of PBM (three 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.
Measured: 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.
Measured: 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.
Measured: End of PBM (three 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.
Measured: Three weeks post-PBM
Secondary outcomes (6)
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.
Measured: 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.
Measured: End of PBM (three weeks post-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.
Measured: 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).
Measured: 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).
Measured: End of PBM (three 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).
Measured: Three weeks post-PBM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start31 Jan 2022
- Primary completion15 Nov 2023
- Study completion10 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, Prof. Dr., Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199389
- Sponsor's protocol ID
- 2021/155
- Acronym
- NeuroLight
- Status last verified
- Mar 2024
- First submitted
- 6 Jan 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Claes M, Lodewijckx J, Robijns J, Hermans S, Peeters P, Mebis J. Evaluating the efficacy of photobiomodulation therapy in the management of chemotherapy-induced peripheral neuropathy: a pilot trial (NEUROLIGHT trial). Lasers Med Sci. 2026 Mar 14;41(1):57. doi: 10.1007/s10103-026-04852-1.
PubMed 41831101
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Pilot Trial
- ClinicalTrials.gov ID
- NCT05199389
- Acronym / sponsor ID
- NeuroLight / 2021/155
- Keywords
- Photobiomodulation therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 10 Nov 2028 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM1 group | Experimental | Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)The patients allocated to the first PBM-group will receive six PBM sessions of 6 J/cm² over three weeks (2x/week). |
| PBM2 group | Experimental | Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)The patients allocated to the first PBM-group will receive six PBM sessions of 8 J/cm² over three weeks (2x/week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | PBM1 group, PBM2 group |
Primary outcome
Modified total neuropathy score (mTNS)
Time frame: Baseline
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.
Modified total neuropathy score (mTNS)
Time frame: End of PBM (three weeks post-baseline)
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.
Modified total neuropathy score (mTNS)
Time frame: 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.
Pain score
Time frame: Baseline
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.
Pain score
Time frame: End of PBM (three weeks post-baseline)
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.
Pain score
Time frame: 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.
Mobility score
Time frame: Baseline
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.
Mobility score
Time frame: End of PBM (three weeks post-baseline)
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.
Mobility score
Time frame: 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.
6 secondary outcomes
Quality of life score
Time frame: Baseline
Quality of life score
Time frame: End of PBM (three weeks post-baseline)
Quality of life score
Time frame: Three weeks post-PBM
Satisfaction score
Time frame: Baseline
Satisfaction score
Time frame: End of PBM (three weeks post-baseline)
Satisfaction score
Time frame: Three weeks post-PBM
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 41831101Claes M, Lodewijckx J, Robijns J, Hermans S, Peeters P, Mebis J. Evaluating the efficacy of photobiomodulation therapy in the management of chemotherapy-induced peripheral neuropathy: a pilot trial (NEUROLIGHT trial). Lasers Med Sci. 2026 Mar 14;41(1):57. doi: 10.1007/s10103-026-04852-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Mebis, Prof. Dr. principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) in people with Chemotherapy-induced Peripheral Neuropathy, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified total neuropathy score (mTNS) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.