PBMT for the Prevention of CIPN
PBMT for the Prevention of CIPN
ne of the most common cancers in women worldwide is breast cancer. A common used therapy in
 early-stage and metastatic breast cancer involves chemotherapy. Taxanes,
 microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in
 breast cancer patients. Unfortunately, this treatment comes with many unfortunate side
 effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side
 effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs.
 Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can
 occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom
 management is possible. Not only will this condition affect the patients' daily activities,
 but a chemotherapy dose reduction could also be necessary, influencing the outcome and
 overall survival rate of the patient.

 A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser
 therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area
 to improve tissue repair and thereby promote functional recovery of peripheral nerves.
 Studies have shown positive results for patients with diabetic neuropathy. However, no
 studies have been undertaken specifically for taxane-induced neuropathy (TIN).

 We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms
 associated with TIN. This can lead to an improved quality of life for the patient and no need
 for a chemotherapy dose reduction.
Inclusion Criteria:

 -  Diagnosed with non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast
 adenocarcinoma

 -  Age 18 years or above

 -  Are planned to undergo at least 3 cycles of taxane treatment (i.e. paclitaxel or
 docetaxel)

 -  Have no documented or observable psychiatric or neurological disorders that might
 interfere with study participation (e.g., dementia or psychosis).

 -  Signed informed consent

 Exclusion Criteria:

 -  Have a history of neuropathy before taxane treatment due to other medical conditions:
 diabetes, peripheral vascular disease, HIV infection, significant degenerative or
 familial neurologic disorder, nerve compression injuries (i.e., carpal tunnel
 syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)

 -  Taking stable doses of medication on prescription or dietary supplements for
 peripheral neuropathy. Related medications are: gabapentin, pregabalin, nortriptyline,
 amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other
 narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12; Patients need to
 agree not to initiate a new therapy two weeks before and during the study period.

 -  Metastatic disease

 -  Have a diagnosis of ethanol addiction or dependence within the past 10 years.

 -  Concurrent chemotherapy with neurotoxic chemotherapeutic agents (i.e. platinum
 compounds or vinca alcaloids)

 -  Severe or unstable cardio- respiratory or musculoskeletal disease