Peripheral NeuropathyAcu-CIPNNCT05673746
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
A study testing Acupuncture in people with Peripheral Neuropathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, 40138
Claudio Zamagni, MD, 051 2144548 ext. +39, zamagniclaudio.sper@aosp.bo.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology
Rome, 00168
Stefano Magno, MD, 0630157077 ext. +39, stefano.magno@policlinicogemelli.it
About this study
Official title: Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
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.
Read the 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
- Being tested
- Acupuncture, treatment of physician choice, according to the standard of care
- Keywords
- peripheral neuropathy, breast cancer, acupuncture
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
acupuncture administration
treatment of physician choice, according to the standard of careDrug
treatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Procedure: Acupuncture; Drug: treatment of physician choice, according to the standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after the start of treatment
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at last visit, 9 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Sep 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Zamagni MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673746
- Sponsor's protocol ID
- Acu-CIPN
- Acronym
- Acu-CIPN
- Status last verified
- Dec 2022
- First submitted
- 29 May 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05673746
- Acronym / sponsor ID
- Acu-CIPN / Acu-CIPN
- Conditions
- Peripheral Neuropathy
- Keywords
- peripheral neuropathy, breast cancer, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: treatment of physician choice, according to the standard of careTreatment 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 B | Experimental | Procedure: Acupuncture, Drug: treatment of physician choice, according to the standard of careIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupunctureacupuncture administration | Procedure or surgery | Arm B |
| treatment of physician choice, according to the standard of caretreatment of physician choice, according to the standard of care for the treatment of chemotherapy-induced peripheral neuropathy, including neuropathic pain | Drug | Arm A, Arm B |
Primary outcome
Reduction of peripheral neuropathy, including neuropathic pain
Time frame: 6 weeks after the start of treatment
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 secondary outcomes
Reduction of peripheral neuropathy, including neuropathic pain
Time frame: at 3 and 6 weeks after the start of treatment
Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires
Time frame: at 3, 6, 9 weeks after the start of treatment
Improvement of the quality of life, SF-36 questionnaire
Time frame: 6 weeks after the start of treatment
Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire
Time frame: 6 weeks after the start of treatment
Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria
Time frame: at 3, 6, 9 weeks after the start of treatment
Type and frequency of adverse events occurrence due to acupuncture
Time frame: at last visit, 9 weeks from start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Peripheral Neuropathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Zamagni, MD (+390512144548, zamagniclaudio.sper@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of peripheral neuropathy, including neuropathic pain (time frame: 6 weeks after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.