Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer (Acu-CIPN)
Peripheral Neuropathy
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring peripheral neuropathy, breast cancer, acupuncture
Eligibility Criteria
Inclusion Criteria: Female patients ≥18 years. Patients with diagnosis of breast cancer (stage I-III) currently receiving taxane-based chemotherapy (paclitaxel or docetaxel) in neoadjuvant or adjuvant setting, or who have completed taxane-based chemotherapy for no more than 6 months. Concomitant treatment with trastuzumab is allowed in HER-positive patients and/or hormone therapy in patients with hormone-sensitive breast cancer. Chemotherapy-induced peripheral neuropathy graded 1-3, according to NCICTCAE v 4.03 criteria, for at least one week and for no more than 6 months after the completion of chemotherapy regimen. Neuropathic pain with ≥4 points in the numeric scale rate for at least one week Informed consent signed before any study-specific procedure Exclusion Criteria: Patients with diagnosis of metastatic breast cancer Pre-existing peripheral neuropathy in the 28-day period before the start of chemotherapy Any pre-existing condition which can both lead to or be a concomitant factor for neuropathy onset, such as not controlled diabetes mellitus, paralysis, multiple sclerosis, AIDS and Herpes Zoster Patients with amputation and/or severe peripheral vascular disease (peripheral revascularization interventions needed, AOCP> stage II, rheumatologic disorders affecting arteriole or microcirculation) Patient with history of spinal cord surgery Patient with history of chronic alcoholism Concomitant use of pharmacological agents which can cause neuropathic pain as an adverse event, except for chemotherapy Patient who already experienced acupuncture for any condition Patient currently in treatment with duloxetine, gabapentin, pregabalin or other drugs for the treatment of neuropathic pain Patient with history of psychiatric disorders before breast cancer diagnosis (major depressive disorders, bipolar disorder, suicidal tendency)
Sites / Locations
- Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica AddariiRecruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A
Arm B
Treatment for peripheral neuropathy (including neuropathic pain), according to the standard of care (e.g. "Cetirizine", "Gabapentin"). Patient will be followed-up as per protocol for a total of 9 weeks .
In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment.