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

Study Overview
=================
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.

Official Title
-----------------
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study

Conditions
-----------------
Peripheral Neuropathy

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Drug: treatment of physician choice, according to the standard of care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>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 . | Drug: treatment of physician choice, according to the standard of care<br>* treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain<br>|
| Experimental: Arm B<br>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. | Procedure: Acupuncture<br>* acupuncture administration<br>Drug: treatment of physician choice, according to the standard of care<br>* treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of peripheral neuropathy, including neuropathic pain | Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) after the 6-week treatment period versus before the start of treatment, greater in the experimental than in the control arm. | 6 weeks after the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of peripheral neuropathy, including neuropathic pain | Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) at 3 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental than in the control arm | at 3 and 6 weeks after the start of treatment | 
| Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires | Improvement of peripheral neuropathy, including neuropathic pain perceived by patients, assessed with EORTC QLQ-CIPN20/QLQ-C30 questionnaires, at 3, 6 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to the control arm. | at 3, 6, 9 weeks after the start of treatment | 
| Improvement of the quality of life, SF-36 questionnaire | Improvement of the quality of life as assessed with the SF-36 questionnaire at 6 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to control arm. | 6 weeks after the start of treatment | 
| Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire | Improvement of peripheral neuropathy, including neuropathic pain perceived by patients, assessed with BPI questionnaire, at 6 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to control arm. | 6 weeks after the start of treatment | 
| Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria | Improvement of peripheral neuropathy, including neuropathic pain evaluated by the clinician according to NCICTCAE v 4.03 criteria, at 3, 6 and 9 weeks after the start of treatment versus before the start of treatment, greater in the experimental arm compared to the control arm. | at 3, 6, 9 weeks after the start of treatment | 
| Type and frequency of adverse events occurrence due to acupuncture | Comparison of the type and frequency of adverse events occurred in the two treatment arms. | at last visit, 9 weeks from start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral neuropathy, breast cancer, acupuncture