Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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. The resulting sensorimotor dysfunction significantly impairs patients' quality of life, necessitates dose reduction or treatment discontinuation, and ultimately affects survival outcomes. Currently, no prophylactic pharmacological or non-pharmacological interventions have received Grade I recommendations in domestic or international guidelines and expert consensuses. The compression therapy demonstrated definite preventive value in the POLAR trial. Its low cost and high tolerability confer substantial clinical applicability, earning it a Grade III recommendation in ESMO guidelines. Meanwhile, single-arm trials of acupuncture have reported a 51.2% symptom relief rate and a trend toward reduced high-grade CIPN. As non-pharmacological interventions, acupuncture and compression therapy hold complementary potential in preventing taxane-induced CIPN: compression therapy locally blocks drug exposure, while acupuncture systemically regulates neural function.However, three core challenges persist in the current research field: insufficient evidence quality for single-intervention strategies, lack of systematic evaluation of combined interventions, and the absence of risk-stratified prevention models. To address these gaps, this study aims to conduct a prospective randomized controlled trial to concurrently evaluate the preventive efficacy of compression therapy, acupuncture, and their combination for taxane-induced CIPN. The goal is to provide high-level evidence-based medicine to support the development of individualized prevention strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Compression
Other interventionTwo layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion.
Acupuncture
Other interventionAcupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.
Sham acupuncture
Other interventionA shallow needling at non-acupoint sites (sham acupuncture) is adopted. The stimulation locations are non-acupoint areas 1-2 cun away from the standard acupoint positions. For the sham acupuncture group, needles are inserted superficially to a depth of 2-3 mm without manipulation, with the endpoint of no deqi sensation. Operational elements including needle type, patient posture, disinfection method, needle insertion technique, needle retention time, and needle withdrawal technique are identical between the sham acupuncture group and the active acupuncture group.
Compression combined with acupuncture
Other interventionTwo layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion. Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.
Treatment groups
384 Participants
are divided into 4 treatment groupsGroup A: CompressionExperimental treatment 1 intervention
Group B: AcupunctureExperimental treatment 1 intervention
Group C: Compression combined with acupunctureExperimental treatment 1 intervention
Group D: Sham acupuncturePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
The incidence of CIPN ≥ grade 2 is assessed according to the NCI-CTCAE v5.0 criteria.
Time frame
12 weeks after the initiation of chemotherapySecondary outcomes
1
Incidence of CIPN
The incidence of CIPN at 6 and 12 weeks after chemotherapy initiation, and at 12 and 24 weeks after chemotherapy completion
Time frame
6 and 12 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion2
Incidence of grade ≥2 CIPN at 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
The incidence of CIPN ≥2 grade at 6 weeks after chemotherapy initiation, 12 weeks after chemotherapy completion, and 24 weeks after chemotherapy completion.
Time frame
6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion3
Assessment of quality of life via the EORTC QLQ-C30 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30). It contains 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), a global health and quality of life scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact). The global health and quality of life scale uses a 7-point scale scoring with anchors (1=very poor and 7=excellent); the other items are scored on a 4 point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much).
Time frame
Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.4
Assessment of sensation and motor function via the EORTC QLQ-CIPN20 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (EORTC QLQ-CIPN20). It contains 20 items divided into 3 subscales assessing sensory, motor and autonomic symptoms. Each item is scored on a Likert scale ranging from 1 'not at all' to 4 'very much'. Scores are transformed to a 0-100 scale, with higher scores representing more complaints.
Time frame
Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.Other outcomes
1
Blood sample analysis
Compare the differences in NfL levels, metabolites and other aspects among blood samples from different groups to identify molecular markers potentially associated with the occurrence of CIPN.
Time frame
3 months (before and after taxane therapy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov