Clinical trial NCT05673746: Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
Official title: Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: peripheral neuropathy
breast cancer
acupuncture
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2023-01-06
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with breast cancer diagnosis and taxane-induced peripheral neuropathy since at least 1 week (CTCAE4.0 Grade 1-3 and NRS≥4) will be enrolled. Patients will be randomized 1:1 in the 2 treatment arms: treatment of physician choice as per standard of care vs acupuncture in addition to standard of care treatment. In experimental arm acupuncture will be performed twice a week for 6 weeks, for a total of 12 sessions. Peripheral neuropathy symptoms and pain at hands and foot will be recorded every day by patients by use of NRS scale. At baseline and every 3 weeks patients will complete CIPN20, EORTC QL30, SF-36 and BPI in order to compare the course of neuropathic pain and quality of life in the 2 arms.

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)

Primary outcomes:
measure: Reduction of peripheral neuropathy, including neuropathic pain
timeFrame: 6 weeks after the start of treatment
Secondary outcomes:
measure: Reduction of peripheral neuropathy, including neuropathic pain
timeFrame: at 3 and 6 weeks after the start of treatment
measure: Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires
timeFrame: at 3, 6, 9 weeks after the start of treatment
measure: Improvement of the quality of life, SF-36 questionnaire
timeFrame: 6 weeks after the start of treatment
measure: Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire
timeFrame: 6 weeks after the start of treatment
measure: Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria
timeFrame: at 3, 6, 9 weeks after the start of treatment
measure: Type and frequency of adverse events occurrence due to acupuncture
timeFrame: at last visit, 9 weeks from start of treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology
Study officials:
References: