LANTERN - LAser Nerve ThERapy for chemotherapy Neurotoxicity
LANTERN (LAser Nerve ThERapy for chemotherapy Neurotoxicity): Randomized controlled phase 2 trial evaluating laser photobiomodulation for the treatment of chemotherapy-induced peripheral neuropathy (CIPN)
Concord Cancer Centre
45 participants
Mar 1, 2020
Interventional
Conditions
Summary
The study aims to assess whether laser treatment (also called photobiomodulation) can help with neurotoxicity from chemotherapy. Photobiomodulation is the use of a low-power laser to improve the nerve damage. Who is it for? You may be eligible for this study if you are male or female, aged 18 years or older with chemotherapy-induced peripheral neuropathy symptoms. There must be at least 3 months following last exposure to neurotoxic chemotherapy, including taxane and platinum classes. Study details All participants in the study will be randomly allocated (50/50) chance to one of the following treatments: 1. Laser treatment to the hands, feet and back for 6 weeks. 2. The control treatment, which is the same (including laser treatment), however the laser source is covered up. This means people in the control group do not know which treatment they are getting. During the study, the participants wear black goggles to prevent them from identifying their treatment. While on the study, participants will be asked about their symptoms, their day-to-day function and have a physical exam focused on nerves. It is hoped this laser treatment will improve nerve symptoms in the patient population and help inform a larger study with more patients.
Eligibility
Inclusion Criteria7
- Males or females with chemotherapy-induced peripheral neuropathy symptoms;
- At least 3 months following last exposure to neurotoxic chemotherapy, including taxane and platinum classes
- Age >18 years
- Agree not to undertake any complementary therapy for peripheral neuropathy for the duration of participation on the study
- Speak and read sufficient English to answer the questionnaires
- Available for treatment and follow up visits
- Signed, written informed consent
Exclusion Criteria5
- Inability to lie supine for a 30-minute period
- Open wound or ulcer over the treatment area
- Clinical diagnosis of peripheral neuropathy from another cause, eg. diabetic peripheral neuropathy, B12 or folate deficiency, alcoholic neuropathy, or demyelination. Note diabetes is not a specific exclusion.
- Uncontrolled psychiatric illness, dementia or cognitive dysfunction that in the opinion of the principal investigator may interfere with the ability to complete neurotoxicity assessments
- Life expectancy of <3 months
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Interventions
Photobiomodulation (PBM) involves non-ionising, low power, laser light which has anti-inflammatory and regenerative effects. Laser PBM is the study intervention in this trial. Patients receive laser PBM twice per week for 6 consecutive weeks, a total of 12 sessions. During the intervention the laser is applied to the interdigital spaces of the hands and feet and the C6-T1 and L5-S1 nerve roots bilaterally. Duration of the treatment will be approximately 30 minutes, twice a week for 6 weeks. Each point will receive a starting dose of 1 Joule for the first session, then escalated to 2 Joules per point for subsequent sessions as tolerated. The intervention will be administered by a medical professional accredited in laser safety. Each treatment, including any adverse effects, will be recorded on a case report form. Laser treatment will be given to patients at least 3 months following completion of their systemic chemotherapy. Patients who have not completed chemotherapy are not eligible to participate.
Locations(1)
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ACTRN12619001672145