Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborator: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)