taxane-induced peripheral neuropathy
Conditions
Interventions
Group 1: Acupuncture (12 semi-standardized manual treatments over 10 weeks)
Group 2: Waitinglist (waiting time 10 weeks, susequently 12 semi-standardized manual acupuncture treatments over 10 weeks)
Sponsors
Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, Klinikum der LMU München
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: peripheral neuropathy that had commenced during taxane-based (paclitaxel / docetaxel) chemotherapy (TIPN) for breast cancer, Age at least 18 years, chemotherapy completed
Exclusion criteria
Exclusion criteria: minority, pregnancy or breastfeeding, lack of German skills, illiteracy, lack of compliance, chemotherapy with Paclitaxel/Docetaxel not completed, diabetes mellitus, other neuropathies besides TIPN, acute or chronic pain conditions besides TIPN, surgery in the last 3 months, severe heart disease, severe lung disease, severe kidney disease, severe neurological disease, depression, schizophrenia, dementia, other malignancies besides breast cancer, severe skin alterations such as burns, acupuncture of transcutaneous nerve stimulation within the last four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline adjusted difference in the Neuropathic Pain Inventory (NPSI) between the ACU and the WL group at the time point after acupuncture and waiting time, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline adjusted difference in the NPSI between study groups at the time point 10 weeks after acupuncture / after acupuncture subsequent to waiting time. Baseline adjusted differences in secondary outcome measures (see below) at the time points after acupuncture / after waiting time as well as 10 weeks after acupuncture / after acupuncture subsequent to waiting time. Secondary outcome measures: Pain at rest as evaluated by the numeric rating scale (NRS 0 - 10) , Pain during exertion as evaluated by the NRS (0 - 10), Numbness as evaluated by the NRS (0 - 10) Foreign Body senstation as evaluated by the NRS (0 - 10), WHO-5 Mental Wellbeing Index, Sensory thresholds according to the standardized test battery for quantitative sensory testing validated by the German Research Network on Neuropathic Pain (DFNS): Warm, cold, mechanical and vibration detection threshold; thermal sensory limen; paradoxical heat sensations; heat, cold, mechanical and pressure pain threshold, mechanical pain sensitivity, temporal summation of pain (wind-up), dynamic mechanical allodynia | — |
Countries
Germany
Contacts
Public ContactDominik Irnich
Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, Klinikum der LMU München
Outcome results
None listed