Chemotherapy Induced Peripheral NeuropathyENLNCT07681921
Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy
A study testing Photobiomodulation in people with Chemotherapy Induced Peripheral Neuropathy, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
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. 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?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2026to 31 Dec 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
- All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.
- 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)
- Be able to understand the ICF and study-related questionnaires
- Signed informed consent
Who cannot join
- severe or unstable cardio-respiratory or musculoskeletal disease
- Peripheral neuropathy previous to chemotherapy
- Receiving potentially neurotoxic therapies other than given for cancer treatment
- Interruption of more than two consecutive laser treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. 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. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (PN) is a common side-effect of many anti-neoplastic agents; its prevalence is estimated to 20-50% but varies considerably according to many factors and might actually be underreported. PN is increasingly reported as a complication of cancer immunotherapy and various targeted therapies currently used for the treatment of cancer.
PN typically causes disabling, sensitive (paresthesia, dysesthesia, allodynia, loss of sensation), but can also cause motor dysfunction (muscle weakness, fatigue) and autonomic dysfunction (digestive disorders, orthostatic hypotension); once established, regression of symptoms is slow. The pathobiology of chemotherapy-induced PN is mainly unknown despite the documented involvement of neuroinflammatory, mitochondrial, and vascular mechanisms.
PN often compromises quality of life and is a frequent reason for dose reduction, treatment delay, or premature discontinuation of anticancer therapy.
So far, no standard therapy has been recommended, with the possible exception of duloxetine, which has been associated with a modest symptom improvement in cisplatin-treated patients.
In this context, innovative, non-pharmacological, and well-tolerated strategies are needed. Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), uses specific wavelengths (red or near-infrared) to modulate cellular activity, promote nerve regeneration, reduce inflammation, and regulate pain. Already included in international recommendations for the management of oral mucositis induced by chemotherapy or radiotherapy, PBM is emerging as a potentially effective alternative for other cancer-related toxicities.
A beneficial effect of PBM on diabetic PN and oxaliplatin-induced PN has been reported.
Argenta et al. published a small randomized sham-controlled trial of PBM on chemotherapy-induced PN that indicated a significant reduction in neuropathy symptoms. They found a significant benefit already after 4 weeks of therapy and patients who crossed over from sham laser experienced similar benefits. In a pilot trial, Lodewijckx et al. found a considerable decrease in symptoms of chemotherapy-induced PN with PBM. The same group reported " promising " results with PBM for the prevention of chemotherapy-induced PN in breast cancer patients.
Therefore, the investigator plan to evaluate the role of PBM administered to patients with " de novo " early signs of PN that are supposed to be related to ongoing neurotoxic anti-cancer therapy (Bortezomib, Cisplatin, Docetaxel, Enfortumag, Halaven, Oxaliplatin, Paclitaxel, Vinblastine, Vincritsine, Vinorelbine).
The project is therefore part of a proactive approach to supportive care aimed at reducing the early symptoms of PN, improving patients' quality of life, and avoiding the interruption or reduction of cancer therapy doses, using a simple, non-invasive device that has the potential for widespread application.
- Being tested
- Photobiomodulation
- Keywords
- photobiomodulation and peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called Low Level Laser
Patients will receive 20 Joule/cm2
| Study group | Role | What they receive |
|---|---|---|
| PBM group | Experimental | Patient will recieve photobiomodulation of 20J/cm2 twice a week. Receives: Device: Photobiomodulation |
| Sham-PBM group | Sham comparator | Patient will recieve a simulated treatment by photobiomodulation twice a week. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of CIPN measured by modified Total Neurpathy Score m-TNS
Include several simple neurological tests
Measured: At baseline (week 0) and at week 3 and week 6
Secondary outcomes (3)
Pain & satisfaction by Numeric Rating Scale (0-10)
Pain \& satisfaction by Numeric Rating Scale (0-10)
Measured: At baseline (Week0), and Week 3 and Week 6
Mobility by 6min walking test
Mobility by 6min walking test and
Measured: At baseline (Week0), and Week 3 and Week 6
Quality of life by FACT-GOG-NTX questionnair
Quality of life by FACT-GOG-NTX questionnaire
Measured: At baseline (Week0), and Week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681921
- Sponsor's protocol ID
- IJB-EARLYNEUROLASER-2026
- Acronym
- ENL
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy
- ClinicalTrials.gov ID
- NCT07681921
- Acronym / sponsor ID
- ENL / IJB-EARLYNEUROLASER-2026
- Keywords
- photobiomodulation and peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jul 2026 (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.
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. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. 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. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.
Detailed description
Chemotherapy-induced peripheral neuropathy (PN) is a common side-effect of many anti-neoplastic agents; its prevalence is estimated to 20-50% but varies considerably according to many factors and might actually be underreported. PN is increasingly reported as a complication of cancer immunotherapy and various targeted therapies currently used for the treatment of cancer.
PN typically causes disabling, sensitive (paresthesia, dysesthesia, allodynia, loss of sensation), but can also cause motor dysfunction (muscle weakness, fatigue) and autonomic dysfunction (digestive disorders, orthostatic hypotension); once established, regression of symptoms is slow. The pathobiology of chemotherapy-induced PN is mainly unknown despite the documented involvement of neuroinflammatory, mitochondrial, and vascular mechanisms.
PN often compromises quality of life and is a frequent reason for dose reduction, treatment delay, or premature discontinuation of anticancer therapy.
So far, no standard therapy has been recommended, with the possible exception of duloxetine, which has been associated with a modest symptom improvement in cisplatin-treated patients.
In this context, innovative, non-pharmacological, and well-tolerated strategies are needed. Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), uses specific wavelengths (red or near-infrared) to modulate cellular activity, promote nerve regeneration, reduce inflammation, and regulate pain. Already included in international recommendations for the management of oral mucositis induced by chemotherapy or radiotherapy, PBM is emerging as a potentially effective alternative for other cancer-related toxicities.
A beneficial effect of PBM on diabetic PN and oxaliplatin-induced PN has been reported.
Argenta et al. published a small randomized sham-controlled trial of PBM on chemotherapy-induced PN that indicated a significant reduction in neuropathy symptoms. They found a significant benefit already after 4 weeks of therapy and patients who crossed over from sham laser experienced similar benefits. In a pilot trial, Lodewijckx et al. found a considerable decrease in symptoms of chemotherapy-induced PN with PBM. The same group reported " promising " results with PBM for the prevention of chemotherapy-induced PN in breast cancer patients.
Therefore, the investigator plan to evaluate the role of PBM administered to patients with " de novo " early signs of PN that are supposed to be related to ongoing neurotoxic anti-cancer therapy (Bortezomib, Cisplatin, Docetaxel, Enfortumag, Halaven, Oxaliplatin, Paclitaxel, Vinblastine, Vincritsine, Vinorelbine).
The project is therefore part of a proactive approach to supportive care aimed at reducing the early symptoms of PN, improving patients' quality of life, and avoiding the interruption or reduction of cancer therapy doses, using a simple, non-invasive device that has the potential for widespread application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM group | Experimental | Device: PhotobiomodulationPatient will recieve photobiomodulation of 20J/cm2 twice a week. |
| Sham-PBM group | Sham comparator | Device: PhotobiomodulationPatient will recieve a simulated treatment by photobiomodulation twice a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.
- 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)
- Be able to understand the ICF and study-related questionnaires
- Signed informed consent
Key exclusion criteria (4 listed)
- severe or unstable cardio-respiratory or musculoskeletal disease
- Peripheral neuropathy previous to chemotherapy
- Receiving potentially neurotoxic therapies other than given for cancer treatment
- Interruption of more than two consecutive laser treatments
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 |
|---|---|---|
| PhotobiomodulationAlso: Low Level LaserPatients will receive 20 Joule/cm2 | Device | PBM group, Sham-PBM group |
Primary outcome
severity of CIPN measured by modified Total Neurpathy Score m-TNS
Time frame: At baseline (week 0) and at week 3 and week 6
Include several simple neurological tests
3 secondary outcomes
Pain & satisfaction by Numeric Rating Scale (0-10)
Time frame: At baseline (Week0), and Week 3 and Week 6
Mobility by 6min walking test
Time frame: At baseline (Week0), and Week 3 and Week 6
Quality of life by FACT-GOG-NTX questionnair
Time frame: At baseline (Week0), and Week 3 and Week 6
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Chemotherapy Induced Peripheral Neuropathy, run by Jules Bordet Institute 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 5 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
severity of CIPN measured by modified Total Neurpathy Score m-TNS (time frame: At baseline (week 0) and at week 3 and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.