BridgeMD
New treatment option for Cancer Survivors
Official title Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients
ClinicalTrials.gov ID: NCT06834685
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female aged 18 years minimum;
- Patient treated at the Montpellier Cancer Institute for a cancer (whatever the location) requiring a chemotherapy;
- 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...
You likely can't join if
- Patient unable to come twice a week to the Montpellier Cancer Institute;
- 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...
- Patient whose estimated life expectancy is less than 3 months, as estimated by a clinical investigator;
See the full eligibility criteria
- Male or female aged 18 years minimum;
- Patient treated at the Montpellier Cancer Institute for a cancer (whatever the location) requiring a chemotherapy;
- 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...
- 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.
- Patient unable to come twice a week to the Montpellier Cancer Institute;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.