Acupuncture and compression to prevent chemotherapy-induced nerve damage in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with non-recurrent early or intermediate-stage breast cancer scheduled for taxane-based adjuvant or neoadjuvant chemotherapy and without baseline neuropathy will be enrolled at Sun Yat-sen Memorial Hospital. Participants will be assigned to receive compression therapy, acupuncture, sham acupuncture, or a combination of compression plus acupuncture alongside standard chemotherapy. The study will monitor the incidence and severity of CIPN using clinical grading and neuropathy scales throughout treatment and follow-up. The design builds on POLAR trial evidence for compression and prior single-arm acupuncture reports to test individual and combined preventive effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-70 years old and have signed an informed consent form;
2. Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
3. Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
4. No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
5. Cardiac echocardiography showing cardiac ejection fraction within normal range;
6. Eastern Cooperative Oncology Group (ECOG) physical status ≤1;
7. No psychiatric or cognitive impairments, capable of understanding and completing assessment scales;
8. No CIPN at baseline (NCI-CTCAE 5.0 and TNSc grading ≤0);
9. 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 normal, serum creatinine ≤1.5× upper limit of normal;
10. 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.

Exclusion Criteria:

1. Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
2. Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
3. Patients who received acupuncture for other conditions within the past month;
4. Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
5. Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
6. Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
7. Patients with lymphedema in acupuncture stimulation areas;
8. Patients with phobia of electroacupuncture or stainless steel needle allergy;
9. Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;
10. Patients undergoing concurrent anti-tumor therapy or clinical trials;
11. Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;
12. Patients with known allergy history or contraindications to trial procedures;
13. 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 supraventricular or ventricular arrhythmias requiring treatment;
14. Cardiac pacemaker implantation;
15. Known hereditary or acquired bleeding/thrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).

Where it's running

• Breast Tumor Center, Sun Yat-sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jieqiong Liu
• Email: liujieqiong01@163.com
• Phone: 86-13922272706

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.