← Back to all trials
Recruiting
NCT05673746
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
Conditions: Peripheral Neuropathy
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 102
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Location: Italy
Summary
The main purpose of this study is to define whether acupuncture in addition to the treatment of physician choice as per standard of care leads to a greater decrease of neuropathic pain as perceived by women with breast cancer who suffer from chemotherapy-induced peripheral neuropathy.
Peripheral neuropathy and neuropathic pain of hands and foots will be assessed by using a Number Rate Scale (NRS scale) and data will be compared between standard of care treatment group and acupuncture in addition to standard of care treatment group.
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 weekInformed consent signed before any study-specific procedureExclusion Criteria:Patients with diagnosis of metastatic breast cancerPre-existing peripheral neuropathy in the 28-day period before the start of chemotherapyAny 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 ZosterPatients 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 surgeryPatient with history of chronic alcoholismConcomitant use of pharmacological agents which can cause neuropathic pain as an adverse event, except for chemotherapyPatient who already experienced acupuncture for any conditionPatient currently in treatment with duloxetine, gabapentin, pregabalin or other drugs for the treatment of neuropathic painPatient with history of psychiatric disorders before breast cancer diagnosis (major depressive disorders, bipolar disorder, suicidal tendency)
Source: ClinicalTrials.gov (NCT05673746). StuddyBuddy aggregates publicly available trial information.