Clinical trial NCT03391271: PBMT for the Prevention of CIPN
Official title: The Use of Photobiomodulation Therapy for the Prevention of Chemotherapy-induced Peripheral Neuropathy: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2018-01-05
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The modified total neuropathy score (mTNS)
timeFrame: baseline
measure: The modified total neuropathy score (mTNS)
timeFrame: week 6
measure: The modified total neuropathy score (mTNS)
timeFrame: week 12
measure: The modified total neuropathy score (mTNS)
timeFrame: week 15
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)
timeFrame: baseline
measure: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)
timeFrame: week 6
measure: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)
timeFrame: week 12
measure: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)
timeFrame: week 15
measure: Pain evaluation
timeFrame: baseline
measure: Pain evaluation
timeFrame: week 6
measure: Pain evaluation
timeFrame: week 12
measure: Pain evaluation
timeFrame: week 15
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Jessa Hospital
name: jeroen Mebis, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21.