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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression | Experimental | Latex gloves and compression stockings are worn during chemotherapy. |
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| Acupuncture | Experimental | Electroacupuncture treatment is administered after each chemotherapy cycle and continuing consecutively for 3-5 days. |
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| Compression combined with acupuncture | Experimental | Compression therapy will be administered during chemotherapy, combined with consecutive electroacupuncture for 3-5 days after each chemotherapy cycle. |
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| Sham acupuncture | Placebo Comparator | A shallow needling at non-acupoint sites (sham acupuncture) is inserted superficially to a depth of 2-3 mm without manipulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression | Other | Two 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after the initiation of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIPN | The incidence of CIPN at 6 and 12 weeks after chemotherapy initiation, and at 12 and 24 weeks after chemotherapy completion | 6 and 12 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion |
| Incidence of grade ≥2 CIPN at 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months (before and after taxane therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieqiong Liu | Contact | 86-13922272706 | liujieqiong01@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Tumor Center, Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Acupuncture | Other | 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. |
|
| Sham acupuncture | Other | A 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. |
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| Compression combined with acupuncture | Other | Two 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. |
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The incidence of CIPN ≥2 grade at 6 weeks after chemotherapy initiation, 12 weeks after chemotherapy completion, and 24 weeks after chemotherapy completion. |
| 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion |
| 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). | Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy. |
| 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. | Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy. |
| Nail toxicity | Nail toxicity is assessed according to the National Cancer Institute Toxicity Criteria 4.0 (NCI 4.0). | Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy. |
| Objective neurological function | Use quantitative sensory testing to assess vibration perception (128Hz tuning fork, dorsal threshold>8 seconds) and tactile sensation (10g monofilament, no response at ≥2 of 4 hand/foot points). | Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy. |
| Adverse event incidence rate | Adverse events at all levels associated with treatment and interventions | 8 months (during taxane therapy and follow up). |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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