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Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer (Acu-CIPN)

Primary Purpose

Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acupuncture
treatment of physician choice, according to the standard of care
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring peripheral neuropathy, breast cancer, acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica AddariiRecruiting
  • Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
May 29, 2021
Last Updated
December 30, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05673746
Brief Title
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
Acronym
Acu-CIPN
Official Title
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
peripheral neuropathy, breast cancer, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Arm B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture administration
Intervention Type
Drug
Intervention Name(s)
treatment of physician choice, according to the standard of care
Intervention Description
treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain
Primary Outcome Measure Information:
Title
Reduction of peripheral neuropathy, including neuropathic pain
Description
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.
Time Frame
6 weeks after the start of treatment
Secondary Outcome Measure Information:
Title
Reduction of peripheral neuropathy, including neuropathic pain
Description
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
Time Frame
at 3 and 6 weeks after the start of treatment
Title
Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires
Description
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.
Time Frame
at 3, 6, 9 weeks after the start of treatment
Title
Improvement of the quality of life, SF-36 questionnaire
Description
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.
Time Frame
6 weeks after the start of treatment
Title
Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire
Description
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.
Time Frame
6 weeks after the start of treatment
Title
Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria
Description
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.
Time Frame
at 3, 6, 9 weeks after the start of treatment
Title
Type and frequency of adverse events occurrence due to acupuncture
Description
Comparison of the type and frequency of adverse events occurred in the two treatment arms.
Time Frame
at last visit, 9 weeks from start of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Zamagni, MD
Phone
+390512144548
Email
zamagniclaudio.sper@aosp.bo.it
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Zamagni, MD
Phone
051 2144548
Ext
+39
Email
zamagniclaudio.sper@aosp.bo.it
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Magno, MD
Phone
0630157077
Ext
+39
Email
stefano.magno@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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