Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy).
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial
Overview
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.
Interventions
- Device Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.
Primary outcome measures
- Modified total neuropathy score (mTNS) [Time frame: Baseline]
- Modified total neuropathy score (mTNS) [Time frame: End of PBM (six weeks post-baseline)]
- Modified total neuropathy score (mTNS) [Time frame: Three weeks post-PBM]
- Pain score [Time frame: Baseline]
- Pain score [Time frame: End of PBM (six weeks post-baseline)]
- Pain score [Time frame: Three weeks post-PBM]
- Mobility score [Time frame: Baseline]
- Mobility score [Time frame: End of PBM (six weeks post-baseline)]
- Mobility score [Time frame: Three weeks post-PBM]
Secondary outcome measures (6)
- Quality of life score [Time frame: Baseline]
- Quality of life score [Time frame: End of PBM (six weeks post-baseline)]
- Quality of life score [Time frame: Three weeks post-PBM]
- Satisfaction score [Time frame: Baseline]
- Satisfaction score [Time frame: End of PBM (six weeks post-baseline)]
- satisfaction score [Time frame: Three weeks post-PBM]
Eligibility criteria
Inclusion criteria
- Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
- Diagnosed with CIPN
- Age 18 years or above
- Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
- Dutch-speaking
- Signed informed consent
Exclusion criteria
- Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
- Severe or unstable cardio- respiratory or musculoskeletal disease
- Interruption of more than two consecutive laser treatments
- Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Jessa Hospital — Hasselt
Identifiers
NCT: NCT05763706 · 2023/007