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

NCT ID: NCT05673746

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-12-31

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.

Conditions

Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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 .

Group Type: ACTIVE_COMPARATOR

treatment of physician choice, according to the standard of care

Intervention Type: DRUG

treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain

Arm B

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

acupuncture administration

treatment of physician choice, according to the standard of care

Intervention Type: DRUG

treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain

Interventions

Acupuncture

acupuncture administration

Intervention Type: PROCEDURE

treatment of physician choice, according to the standard of care

treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Claudio Zamagni MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii

Bologna, , Italy

Site Status: RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Claudio Zamagni, MD

Role: CONTACT

zamagniclaudio.sper@aosp.bo.it

+390512144548

Facility Contacts

Claudio Zamagni, MD

Role: primary

zamagniclaudio.sper@aosp.bo.it

051 2144548 ext. +39

Stefano Magno, MD

Role: primary

stefano.magno@policlinicogemelli.it

0630157077 ext. +39

Other Identifiers

Acu-CIPN

Identifier Type: -

Identifier Source: org_study_id