Breast CancerCIPNNCT06772935
Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer
A study testing Electro-acupuncture in people with Breast Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial summary
Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Electro-acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients diagnosed by pathology;
- EOOG score is 0 or 1;
- The age range for enrollment is between 18 and 75 years old; ④ Accept chemotherapy regimens based on taxane drugs (alone or in combination);
- ⑤ Previously received taxane chemotherapy for more than 6 months;
- ⑥ According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0, reporting CIPN symptoms of grade 1 or higher for more than 2 weeks;
- ⑦ Voluntarily participate in this clinical trial and sign the informed consent form;
- Accept regular follow-up visits; ⑨ There is complete pathological data available.
Who cannot join
- Non breast cancer patients;
- Received electroacupuncture treatment within 6 months prior to the start of the study;
- Patients who experience intolerable toxic side effects during standard dose chemotherapy and terminate the chemotherapy cycle;
- Prior to enrollment, there was a history of peripheral neuropathy;
- Unstable heart disease or myocardial infarction within the first 6 months of the study;
- ⑥ Active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment;
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- ⑦ Uncontrolled epilepsy patients with uncontrolled seizures;
- ⑧ Merge with other malignant tumor patients;
- ⑨ Pregnancy and lactation period;
- ⑩ Refusal to join clinical trial patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital contact
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
Yi Zhao Chief Physician at the Breast Center of Qinghai University Aff, +86-18919007744, 24738297@qq.com
About this study
Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer
Read the detailed description
Chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. The latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. In addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. This study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening SNPs related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. Eligible patients diagnosed as stage I, II or IIIA breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (FACT/GOG-NTX) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN Twenty Item Scale (EORTC QLQ-CIPN20). All items in the above two scales are scored using Likert's 5 and 4 levels. The researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. Laboratory personnel are unaware of all clinical and outcome data.
- Conditions
- Breast Cancer
- Being tested
- Electro-acupuncture
- Keywords
- breast cancer, electroacupuncture, taxanes, SNPs, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureBehavioural
A method of acupuncture that combines acupuncture with a certain frequency of electrical stimulation. Electrical stimulation is a mild level of stimulation intensity that is acceptable to the human body.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture+Routine Nursing Group | Experimental | Not described Receives: Behavioral: Electro-acupuncture |
| Fake electroacupuncture + Routine Nursing Group | Placebo comparator | Not described Receives: Behavioral: Electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX）
This scale is mainly used to evaluate chemotherapy induced peripheral neuropathy (CIPN), especially the neurotoxic reactions in gynecological tumor treatment. Through this scale, it is possible to quantify the neurotoxic symptoms that patients experience after receiving chemotherapy, such as sensory abnormalities, motor dysfunction, etc., in order to better monitor and manage the patient's health status.
Measured: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
Secondary outcomes (1)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20.
This scale is used to evaluate the impact of chemotherapy induced peripheral neuropathy (CIPN) on the quality of life of patients.
Measured: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772935
- Sponsor's protocol ID
- AHQU-2025001
- Acronym
- CIPN
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT06772935
- Acronym / sponsor ID
- CIPN / AHQU-2025001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, electroacupuncture, taxanes, SNPs, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2025 (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.
Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer
Detailed description
Chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. The latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. In addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. This study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening SNPs related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. Eligible patients diagnosed as stage I, II or IIIA breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (FACT/GOG-NTX) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN Twenty Item Scale (EORTC QLQ-CIPN20). All items in the above two scales are scored using Likert's 5 and 4 levels. The researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. Laboratory personnel are unaware of all clinical and outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture+Routine Nursing Group | Experimental | Behavioral: Electro-acupuncture |
| Fake electroacupuncture + Routine Nursing Group | Placebo comparator | Behavioral: Electro-acupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Breast cancer patients diagnosed by pathology;
- ⑤ Previously received taxane chemotherapy for more than 6 months;
- ⑥ According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0, reporting CIPN symptoms of grade 1 or higher for more than 2 weeks;
- ⑦ Voluntarily participate in this clinical trial and sign the informed consent form;
Key exclusion criteria (10 listed)
- Non breast cancer patients;
- ⑥ Active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment;
- ⑦ Uncontrolled epilepsy patients with uncontrolled seizures;
- ⑧ Merge with other malignant tumor patients;
- ⑨ Pregnancy and lactation period;
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 |
|---|---|---|
| Electro-acupunctureA method of acupuncture that combines acupuncture with a certain frequency of electrical stimulation. Electrical stimulation is a mild level of stimulation intensity that is acceptable to the human body. | Behavioural | Electroacupuncture+Routine Nursing Group, Fake electroacupuncture + Routine Nursing Group |
Primary outcome
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX）
Time frame: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
This scale is mainly used to evaluate chemotherapy induced peripheral neuropathy (CIPN), especially the neurotoxic reactions in gynecological tumor treatment. Through this scale, it is possible to quantify the neurotoxic symptoms that patients experience after receiving chemotherapy, such as sensory abnormalities, motor dysfunction, etc., in order to better monitor and manage the patient's health status.
1 secondary outcome
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20.
Time frame: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture in people with Breast Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoshuang Shen G Administrative Director of Breast Center, Affiliated Hospital (+86-18729989935, zywm0001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX） (time frame: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).). 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 14 Jan 2025.