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

NCT05673746 | Unknown DMC

• 1 other identifier: Acu-CIPN
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Neuropathy

Keywords

peripheral neuropathy; breast cancer; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reduction of peripheral neuropathy, including neuropathic pain

  at 3 and 6 weeks after the start of treatment

• Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires

  at 3, 6, 9 weeks after the start of treatment

• Improvement of the quality of life, SF-36 questionnaire

  6 weeks after the start of treatment

• Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire

  6 weeks after the start of treatment

• Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria

  at 3, 6, 9 weeks after the start of treatment

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Arm B

EXPERIMENTAL

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; Drug: treatment of physician choice, according to the standard of care

Interventions

Acupuncture PROCEDURE

acupuncture administration

Arm B

treatment of physician choice, according to the standard of care DRUG

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (2)

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

Bologna, 40138, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Claudio Zamagni, MD

CONTACT

+390512144548; zamagniclaudio.sper@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: January 6, 2023
• Study Start: September 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)