Cancer SurvivorsNEUROdouxNCT06834685
Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients
A study testing Photobiomodulation sessions in people with Cancer Survivors and Peripheral Neuropathic Pain, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors, Peripheral Neuropathic Pain
- What is being tested?
- Photobiomodulation sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Oct 2025to 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
- Male or female aged 18 years minimum;
- Patient with cancer, whatever the location;
- Patient with significant NP defined as a score of 4 at the clinician-rated DN4 ;
- Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy;
- Women of childbearing potential must have a pregnancy urinary test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy);
- Effective contraception for women of childbearing age
Show all 9Show fewer
- Patient having signed informed consent prior to any study procedure;
- Patient affiliated to a French social protection system;
- Patient sufficiently fluent in French to complete questionnaires, as the investigator clinical discretion.
Who cannot join
- Patient unable to come twice a week to the investigator center;
- Patient unable to sit for a 30-minutes period;
- Patient with an open wound or ulcer on the treatment area;
- Patient whose diagnosis of peripheral neuropathy is due to another cause (n.b., diabetes without neuropathy will not be a specific exclusion);
- Patient with uncontrolled psychiatric illness or neurocognitive impairment that may interfere with assessments, as the investigator clinical discretion;
- Patient whose estimated life expectancy is less than 3 months, as estimated by a clinical investigator;
Show all 17Show fewer
- Patient using another concurrent non-pharmacological intervention or complementary therapy for neuropathy during the study;
- Patient who has been treated with CAPSAISINE during the previous 3 months;
- Patient with pacemaker;
- Epileptic patient;
- Patient with photosensitive medications, or any medical condition causing sensitivity to light (n.b., Lupus);
- Pregnant and/or breastfeeding woman;
- Patient with primary tumor and/or metastases in areas to be treated by BPM (i.e., hands and/or feet);
- Patient with pre-existing eye disease (such as maculopathy, glaucoma, cataract and retinal lesions), or a history of family eye diseases;
- Patient who has been already been treated with photobiomodulation on the area of interest.
- Participation in another concomitant clinical study with neuropathic pain or chemo-induced peripheral neuropathy as the primary endpoint.
- Presence of a tattoo on the area to be treated.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
ICM
Montpellier, 34298
Estelle GUERDOUX, PHD, 0467612468 ext. +33, estelle.guerdoux@icm.unicancer.fr
- Not yet recruiting
Centre Azuréen de Cancérologie
Mougins, Alpes Maritimes, 06250
Antoine BRACCINI, a.braccini@cac-mougins.fr
About this study
Official title: Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy: a Randomized, Non-comparative, Placebo-controlled, Single-blinded, Phase II Clinical Trial in Cancer Patients
Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in "gloves and socks") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders).
In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM).
PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.
- Conditions
- Cancer Survivors, Peripheral Neuropathic Pain
- Being tested
- Photobiomodulation sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation sessionsDevice
The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Photobiomodulation sessions (2 per week for 4 weeks, 8 sessions in total) will be delivered by certified laser safety clinicians (i.e., algologists, pain nurses or neuropsychologists).
The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm. The light will be applied to all hands and/or feet for 13 minutes. The order of transfer between feet and hands will be counterbalanced so that, half of the sessions will have started with feet, and the other half will have started with hands. The dose will be specified at each session.
Patients will be treated in a sitting position (to treat the hands) or a semi-seated position (for feet). They will wear opaque glasses to ensure the safety of the laser and the blind condition of treatment Receives: Device: Photobiomodulation sessions |
| Control arm | No intervention | In the sham therapy, patients will have the same procedure as the laser intervention (i.e., visit schedule, eye mask, equipment, and application body regions), but without joules. Patients in this placebo arm will have the opportunity to receive the real treatment at the end of the study if they wish. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks
Measured: from the baseline to 12 weeks after the treatment
Secondary outcomes (12)
Description of the evolution of neuropathic pain
description by the scores of the clinician-rated neuropathic pain questionnaire (from 0 to 10, 0 no neuropathic pain, 10 : worst neuropatic pain)
Measured: from the baseline to 6 months after the treatment
Description of the evolution of neuropathic pain
description by the scores of the self-questionnaire Neuropathic Pain Symptom Inventory (from 0 to 100, 0 no neuropathic pain, 100 : worst neuropatic pain)
Measured: from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
The global pain will be assessed using the scores of the self-questionnaire Brief Pain Inventory (from 0 to 110, 0 no neuropathic pain, 110 : worst neuropatic pain)
Measured: from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
The global pain will be assessed using the scores of the Numeric Scale of pain (from 0 to 10, 0 no pain, 10 worst pain)
Measured: from the baseline to 6 months after the treatment
Description of the evolution of the Chemotherapy-induced peripheral neuropathy
The chemotherapy-induced peripheral neuropathy will be described using the scores of the self-questionnaire FACT/GOG-Ntx-13, and the grade of chemotherapy-induced peripheral neuropathy assessed by the clinician via the Common Terminology Criteria for Adverse Events (ranging from 0 to 5, a high score indicates a strong neuropathy).
Measured: from the baseline to 6 months after the treatment
Exploration of the evolution of quality of life
The quality of life will be explored using the self-questionnaire Functional Assessment of Chronic illness Therapy-Global scores [the global score and its 4 sub-scales scores (physical, social/family, emotional, functional] and the number of falls reported by the patient during the last month (from 0 to 108, 0 bad quality of life, 108 good quality of life)
Measured: from the baseline to 6 months after the treatment
Exploration of the evolution of sleep disorders
Sleep disorders will be explored using the self-assessment Sleep Severity Index (ISI).
Measured: from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Neurocognitive functioning will be assessed using the clinician-rated scores of the test modified-Delis-Kaplan Executive Function System (m-DKEFS)
Measured: from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Neurocognitive functioning will be assessed using the scores of the Trail Making Test (TMT A and B)
Measured: from the baseline to 6 months after the treatment
Assessment of the photobiomodulation adherence
The adherence to the intervention will be assessed by the number of PBM sessions performed by patients
Measured: from the baseline to 4 weeks after the beginning of the treatment
Evaluation of the safety of the photobiomodulation
The safety of PBM will be assessed by the number and the severity of target adverse events recorded during the study period, using the CTCAE scale (v5.0)
Measured: from the baseline to 6 months after the treatment
Assessment of emotional distress
Emotional distress will be measured by the score of the Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline, at the end of photobiomodulation treatment (4 weeks, 8 weeks and 12 weeks)
Measured: from the baseline to 4 weeks, 8 weeks and 12 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start7 Oct 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle GUERDOUX, PHD, Study director, INSTITUT REGIONAL DU CANCER DE MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834685
- Sponsor's protocol ID
- PROICM 2024605 NEU
- Other IDs
- 2024-A02524-43
- Acronym
- NEUROdoux
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request
Publications
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21.
PubMed 35312857Teng C, Egger S, Blinman PL, Vardy JL. Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial. Support Care Cancer. 2022 Dec 17;31(1):52. doi: 10.1007/s00520-022-07463-y.
PubMed 36526802Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8.
PubMed 31286228Escritt K, Mann M, Nelson A, Harrop E. Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences. Trials. 2022 May 16;23(1):409. doi: 10.1186/s13063-022-06306-9.
PubMed 35578308D'Souza RS, Alvarez GAM, Dombovy-Johnson M, Eller J, Abd-Elsayed A. Evidence-Based Treatment of Pain in Chemotherapy-Induced Peripheral Neuropathy. Curr Pain Headache Rep. 2023 May;27(5):99-116. doi: 10.1007/s11916-023-01107-4. Epub 2023 Apr 14.
PubMed 37058254Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13.
PubMed 37702983Kerckhove N, Collin A, Conde S, Chaleteix C, Pezet D, Balayssac D, Guastella V. [Chemotherapy-induced peripheral neuropathy: Symptomatology and epidemiology]. Bull Cancer. 2018 Nov;105(11):1020-1032. doi: 10.1016/j.bulcan.2018.07.009. Epub 2018 Sep 20. French.
PubMed 30244980Rao V, Bhushan R, Kumari P, Cheruku SP, Ravichandiran V, Kumar N. Chemobrain: A review on mechanistic insight, targets and treatments. Adv Cancer Res. 2022;155:29-76. doi: 10.1016/bs.acr.2022.04.001. Epub 2022 May 11.
PubMed 35779876Ong WY, Stohler CS, Herr DR. Role of the Prefrontal Cortex in Pain Processing. Mol Neurobiol. 2019 Feb;56(2):1137-1166. doi: 10.1007/s12035-018-1130-9. Epub 2018 Jun 6.
PubMed 29876878McCrary JM, Goldstein D, Trinh T, Timmins HC, Li T, Menant J, Friedlander M, Lewis CR, Hertzberg M, O'Neill S, King T, Bosco A, Harrison M, Park SB. Balance Deficits and Functional Disability in Cancer Survivors Exposed to Neurotoxic Cancer Treatments. J Natl Compr Canc Netw. 2019 Aug 1;17(8):949-955. doi: 10.6004/jnccn.2019.7290.
PubMed 31390588Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
PubMed 28586243Hong JS, Tian J, Wu LH. The influence of chemotherapy-induced neurotoxicity on psychological distress and sleep disturbance in cancer patients. Curr Oncol. 2014 Aug;21(4):174-80. doi: 10.3747/co.21.1984.
PubMed 25089099Pike CT, Birnbaum HG, Muehlenbein CE, Pohl GM, Natale RB. Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer. Chemother Res Pract. 2012;2012:913848. doi: 10.1155/2012/913848. Epub 2012 Mar 14.
PubMed 22482054Lodewijckx J, Robijns J, Bensadoun RJ, Mebis J. Photobiomodulation Therapy for the Management of Chemotherapy-Induced Peripheral Neuropathy: An Overview. Photobiomodul Photomed Laser Surg. 2020 Jun;38(6):348-354. doi: 10.1089/photob.2019.4771. Epub 2020 May 28.
PubMed 32460667
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy: a Randomized, Non-comparative, Placebo-controlled, Single-blinded, Phase II Clinical Trial in Cancer Patients
- ClinicalTrials.gov ID
- NCT06834685
- Acronym / sponsor ID
- NEUROdoux / PROICM 2024605 NEU
- Conditions
- Cancer Survivors, Peripheral Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Feb 2025 (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) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in "gloves and socks") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders).
In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM).
PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Photobiomodulation sessionsPhotobiomodulation sessions (2 per week for 4 weeks, 8 sessions in total) will be delivered by certified laser safety clinicians (i.e., algologists, pain nurses or neuropsychologists). The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm. The light will be applied to all hands and/or feet for 13 minutes. The order of transfer between feet and hands will be counterbalanced so that, half of the sessions will have started with feet, and the other half will have started with hands. The dose will be specified at each session. Patients will be treated in a sitting position (to treat the hands) or a semi-seated position (for feet). They will wear opaque glasses to ensure the safety of the laser and the blind condition of treatment |
| Control arm | No intervention | –In the sham therapy, patients will have the same procedure as the laser intervention (i.e., visit schedule, eye mask, equipment, and application body regions), but without joules. Patients in this placebo arm will have the opportunity to receive the real treatment at the end of the study if they wish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged 18 years minimum;
- Patient with cancer, whatever the location;
- Patient with significant NP defined as a score of 4 at the clinician-rated DN4 ;
- Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy;
- Women of childbearing potential must have a pregnancy urinary test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy);
Key exclusion criteria (17 listed)
- Patient unable to come twice a week to the investigator center;
- Patient unable to sit for a 30-minutes period;
- Patient with an open wound or ulcer on the treatment area;
- Patient whose diagnosis of peripheral neuropathy is due to another cause (n.b., diabetes without neuropathy will not be a specific exclusion);
- Patient with uncontrolled psychiatric illness or neurocognitive impairment that may interfere with assessments, as the investigator clinical discretion;
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 |
|---|---|---|
| Photobiomodulation sessionsThe treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm | Device | Experimental arm |
Primary outcome
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
Time frame: from the baseline to 12 weeks after the treatment
the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks
12 secondary outcomes
Description of the evolution of neuropathic pain
Time frame: from the baseline to 6 months after the treatment
Description of the evolution of neuropathic pain
Time frame: from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
Time frame: from the baseline to 6 months after the treatment
Exploration of the evolution of global pain measures
Time frame: from the baseline to 6 months after the treatment
Description of the evolution of the Chemotherapy-induced peripheral neuropathy
Time frame: from the baseline to 6 months after the treatment
Exploration of the evolution of quality of life
Time frame: from the baseline to 6 months after the treatment
Exploration of the evolution of sleep disorders
Time frame: from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Time frame: from the baseline to 6 months after the treatment
Description of the evolution of neurocognitive executive functioning
Time frame: from the baseline to 6 months after the treatment
Assessment of the photobiomodulation adherence
Time frame: from the baseline to 4 weeks after the beginning of the treatment
Evaluation of the safety of the photobiomodulation
Time frame: from the baseline to 6 months after the treatment
Assessment of emotional distress
Time frame: from the baseline to 4 weeks, 8 weeks and 12 weeks after the treatment
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 28 Jul 2026.
- Background: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Background: PubMed 35312857Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21.
- Background: PubMed 36526802Teng C, Egger S, Blinman PL, Vardy JL. Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial. Support Care Cancer. 2022 Dec 17;31(1):52. doi: 10.1007/s00520-022-07463-y.
- Background: PubMed 31286228Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8.
- Background: PubMed 35578308Escritt K, Mann M, Nelson A, Harrop E. Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences. Trials. 2022 May 16;23(1):409. doi: 10.1186/s13063-022-06306-9.
- Background: PubMed 37058254D'Souza RS, Alvarez GAM, Dombovy-Johnson M, Eller J, Abd-Elsayed A. Evidence-Based Treatment of Pain in Chemotherapy-Induced Peripheral Neuropathy. Curr Pain Headache Rep. 2023 May;27(5):99-116. doi: 10.1007/s11916-023-01107-4. Epub 2023 Apr 14.
- Background: PubMed 37702983Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13.
- Background: PubMed 30244980Kerckhove N, Collin A, Conde S, Chaleteix C, Pezet D, Balayssac D, Guastella V. [Chemotherapy-induced peripheral neuropathy: Symptomatology and epidemiology]. Bull Cancer. 2018 Nov;105(11):1020-1032. doi: 10.1016/j.bulcan.2018.07.009. Epub 2018 Sep 20. French.
- Background: PubMed 35779876Rao V, Bhushan R, Kumari P, Cheruku SP, Ravichandiran V, Kumar N. Chemobrain: A review on mechanistic insight, targets and treatments. Adv Cancer Res. 2022;155:29-76. doi: 10.1016/bs.acr.2022.04.001. Epub 2022 May 11.
- Background: PubMed 29876878Ong WY, Stohler CS, Herr DR. Role of the Prefrontal Cortex in Pain Processing. Mol Neurobiol. 2019 Feb;56(2):1137-1166. doi: 10.1007/s12035-018-1130-9. Epub 2018 Jun 6.
- Background: PubMed 31390588McCrary JM, Goldstein D, Trinh T, Timmins HC, Li T, Menant J, Friedlander M, Lewis CR, Hertzberg M, O'Neill S, King T, Bosco A, Harrison M, Park SB. Balance Deficits and Functional Disability in Cancer Survivors Exposed to Neurotoxic Cancer Treatments. J Natl Compr Canc Netw. 2019 Aug 1;17(8):949-955. doi: 10.6004/jnccn.2019.7290.
- Background: PubMed 28586243Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request
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RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
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.
Estelle GUERDOUX, PHD study director
INSTITUT REGIONAL DU CANCER DE MONTPELLIER
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation sessions in people with Cancer Survivors and Peripheral Neuropathic Pain, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 28 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 2 sites in France. 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?
Contact Aurore MOUSSION (0467613102 ext. +33, drci-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group (time frame: from the baseline to 12 weeks after the treatment). 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 NCT06834685, which also lists 45 linked publications.
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 28 Jul 2026.