Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06834685

Evaluating Laser Photobiomodulation for Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Phase II Trial in Cancer Patients

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-06-04

70

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatments, affecting many patients with symptoms like numbness, pain, and sensory changes mainly in the hands and feet. Neuropathic pain (NP) linked to CIPN significantly impacts quality of life and may lead to chemotherapy delays or dose reductions. Current drug treatments have limited benefits, and there are no proven ways to prevent CIPN, though complementary approaches like photobiomodulation (PBM) show potential. This trial is studying the use of photobiomodulation, a therapy using low-level laser light for its anti-inflammatory and healing effects, to treat neuropathic pain in CIPN. Participants will receive PBM sessions twice a week for four weeks using a specialized ATP38 device that delivers light to the hands and feet. A control group will receive a placebo treatment with the same procedure but no active light. Patients will wear protective glasses during sessions and be seated or semi-seated. Participants will be assessed from the start of treatment through 12 weeks and up to 6 months afterward to measure changes in neuropathic pain, overall pain, CIPN symptoms, quality of life, sleep, cognitive function, emotional distress, and safety. Researchers will also track adherence to the treatment and any side effects. The study aims to evaluate the effectiveness, feasibility, and safety of PBM for managing neuropathic pain in cancer patients with CIPN, with total participation extending beyond six months.

CONDITIONS

Brief Title

Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years minimum
  • Patient treated at the Montpellier Cancer Institute for any cancer requiring chemotherapy
  • Patient with significant neuropathic pain defined by a clinician-rated DN4 score of 4
  • Neuropathic pain lasting at least 3 months after adjuvant or neo-adjuvant chemotherapy
  • Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment
  • Women without reproductive potential include postmenopausal or permanently sterilized women
  • Effective contraception for women of childbearing age
  • Patient has 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 determined by the investigator
Not Eligible

You will not qualify if you...

  • Patient unable to attend twice-weekly visits at the Montpellier Cancer Institute
  • Patient unable to sit for a 30-minute period
  • Presence of an open wound or ulcer on the treatment area
  • Peripheral neuropathy caused by conditions other than chemotherapy (diabetes without neuropathy is allowed)
  • Uncontrolled psychiatric illness or neurocognitive impairment interfering with assessments
  • Estimated life expectancy less than 3 months
  • Use of other non-pharmacological or complementary therapies for neuropathy during the study
  • Treatment with capsaisin within the last 3 months
  • Presence of pacemaker
  • Epilepsy
  • Use of photosensitive medications or medical conditions causing light sensitivity (e.g., lupus)
  • Pregnant or breastfeeding women
  • Primary tumor or metastases in hands or feet
  • Pre-existing or family history of eye diseases such as maculopathy, glaucoma, cataract, or retinal lesions
  • Previous photobiomodulation treatment on the area to be treated
  • Participation in another clinical study with neuropathic pain or chemotherapy-induced peripheral neuropathy as the main endpoint
  • Presence of tattoo on the treatment area

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive photobiomodulation sessions or sham therapy twice a week for 4 weeks. Each session involves a 13-minute application of laser or sham light to hands and/or feet while wearing protective glasses.

2 visits per week for 4 weeks (8 sessions in total)

Follow-up

Duration - Up to 6 months after treatment

Participants are monitored for changes in neuropathic pain, quality of life, sleep disorders, neurocognitive functioning, emotional distress, and safety up to 6 months after treatment.

Visits scheduled through 6 months post-treatment for assessments

Trial Site Locations

Total: 1 location

1

ICM

Montpellier, France, 34298

Actively Recruiting

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Research Team

A

Aurore MOUSSION

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis.

Marta Seretny, Gillian L Currie, Emily S Sena...

https://pubmed.ncbi.nlm.nih.gov/25261162

The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial).

Lodewijckx Joy, Robijns Jolien, Claes Marithé...

https://pubmed.ncbi.nlm.nih.gov/35312857

Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial.

Christina Teng, Sam Egger, Prunella L Blinman...

https://pubmed.ncbi.nlm.nih.gov/36526802

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines.

Yehuda Zadik, Praveen R Arany, Eduardo Rodrigues Fregnani...

https://pubmed.ncbi.nlm.nih.gov/31286228

Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences.

Kate Escritt, Mala Mann, Annmarie Nelson...

https://pubmed.ncbi.nlm.nih.gov/35578308