Status:
COMPLETED
PBMT for the Prevention of CIPN
Lead Sponsor:
Hasselt University
Collaborating Sponsors:
Jessa Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03391271
Start Date
November 13 2017
End Date
June 22 2021
Last Update
September 8 2021
Active Locations (1)
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1
Jessa Ziekenhuis
Hasselt, Belgium, 3500