Spots Global Cancer Trial Database for Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

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Trial Identification

Brief Title: 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 ID: NCT05673746

Conditions

Peripheral Neuropathy

Interventions

Acupuncture

treatment of physician choice, according to the standard of care

Study Description

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.