Laser Treatment for Pain from Chemotherapy in Cancer Survivors
Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients
Recruiting
N/AInterventional Study
Cancer SurvivorsPeripheral Neuropathic Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
70 (estimated)
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle · Other
Who this trial is looking for
This trial is looking for cancer survivors with nerve pain caused by chemotherapy. Participants will receive laser treatment to see if it helps reduce their pain.
Are You a Good Fit for This Trial?
Rules you outEpilepsyEye diseasePhotosensitivity conditions
You may be able to join if
I am at least 18 years old.
I have cancer.
I have significant nerve pain rated at least 4 on a pain scale.
I have had nerve pain for at least 3 months after chemotherapy.
I can speak French well enough to complete questionnaires.
I have signed consent to participate.
I use effective contraception if I can get pregnant.
I am part of a French social protection system.
You may not be able to join if
I cannot attend treatment twice a week.
I cannot sit for 30 minutes.
I have an open wound or ulcer on the treatment area.
I have nerve pain caused by another condition.
I have uncontrolled mental health issues that affect assessments.
My doctor thinks I have less than 3 months to live.
I am using another therapy for nerve pain during the study.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, d…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 o…
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* 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;
* 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.
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