BridgeMD
Prevention study for Breast Cancer
Official title Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
ClinicalTrials.gov ID: NCT07377279
What this study is testing
- What it's testing
- As a core component of comprehensive breast cancer treatment, chemotherapy frequently induces chemotherapy-induced peripheral neuropathy (CIPN), particularly with taxane-based agents. The incidence of CIPN reaches 68.1% within the first month of chemotherapy, and over 30% of patients experience persistent symptoms for more than 6 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years old and have signed an informed consent form;
- Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
- Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
- No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
- Cardiac echocardiography showing cardiac ejection fraction within normal range;
You likely can't join if
- Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
- Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy...
- Patients who received acupuncture for other conditions within the past month;
- Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid...
- Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
- Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
See the full eligibility criteria
- Age 18-70 years old and have signed an informed consent form;
- Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
- Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
- No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
- Cardiac echocardiography showing cardiac ejection fraction within normal range;
- Eastern Cooperative Oncology Group (ECOG) physical status ≤1;
- No psychiatric or cognitive impairments, capable of understanding and completing assessment scales;
- No CIPN at baseline (NCI-CTCAE 5.0 and TNSc grading ≤0);
- Good organ function meeting the following criteria: Hb ≥90g/L, WBC ≥3.5×10⁹/L, platelets ≥100×10⁹/L, neutrophils ≥1.5×10⁹/L, AST ≤3× upper limit of normal, ALT ≤3× upper limit of normal, bilirubin ≤1.5× upper limit of...
- Fertile women must agree to use effective contraception for 7 days before first dosing through 24 weeks post-treatment. Fertile women must have a negative serum pregnancy test within 7 days before first dosing.
- Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
- Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
- Patients who received acupuncture for other conditions within the past month;
- Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
- Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
- Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
- Patients with lymphedema in acupuncture stimulation areas;
- Patients with phobia of electroacupuncture or stainless steel needle allergy;
- Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;
- Patients undergoing concurrent anti-tumor therapy or clinical trials;
- Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;
- Patients with known allergy history or contraindications to trial procedures;
- Patients with uncontrolled cardiac symptoms or conditions, including: (1) NYHA class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant...
- Cardiac pacemaker implantation;
- Known hereditary or acquired bleeding/thrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.