Clinical trial · Interventional
Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer
Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study
NCT04461977CI-TRIAL-00077639completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham acupuncture | Other | — | UNRESOLVED |
| True acupuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A - true acupuncture
- description
- The selection of acupuncture points is based on Traditional Chinese Medicine (Wen 2011) and on previous studies (Jeong, 2018; Bao,2018), selected as main points: bilateral "baxie", SJ5, "bafeng", KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment.
- interventionNames
- Other: True acupuncture
- type
- SHAM_COMPARATOR
- label
- B - sham acupuncture
- description
- Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain "de qi", located near the real points in the hands and feet.
- interventionNames
- Other: Sham acupuncture
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years old. * Agreed to sign the Informed Consent Term * ECOG 0-1 * Breast cancer stages I, II and III. * Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m2. * Peripheral sensory neuropathy grade 2 and 3 by the "Common Terminology Criteria for Adverse Events" (CTCAE) v5.0 Exclusion Criteria: * Previous history of peripheral neuropathy due to other comorbidities. * Prior treatment with chemotherapy for cancer other than breast cancer. * Use of medications to treat peripheral neuropathy. * Metastatic disease. * Presence of lymphedema of any degree. * History of coagulopathy or full anticoagulation. * Previous acupuncture treatment for any indication within the last 90 days.
References
Publications (7)
- BACKGROUNDBouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024. PMID 15030944
- BACKGROUNDCella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31. doi: 10.1002/cncr.11578. PMID 12910528
- BACKGROUNDJeong YJ, Kwak MA, Seo JC, Park SH, Bong JG, Shin IH, Park SH. Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. Evid Based Complement Alternat Med. 2018 Oct 21;2018:5367014. doi: 10.1155/2018/5367014. eCollection 2018. PMID 30420895
- BACKGROUNDBao T, Seidman AD, Piulson L, Vertosick E, Chen X, Vickers AJ, Blinder VS, Zhi WI, Li Q, Vahdat LT, Dickler MN, Robson ME, Mao JJ. A phase IIA trial of acupuncture to reduce chemotherapy-induced peripheral neuropathy severity during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in breast cancer patients. Eur J Cancer. 2018 Sep;101:12-19. doi: 10.1016/j.ejca.2018.06.008. Epub 2018 Jul 13. PMID 30007894
- BACKGROUNDde Andrade DC, Ferreira KA, Nishimura CM, Yeng LT, Batista AF, de Sa K, Araujo J, Stump PR, Kaziyama HH, Galhardoni R, Fonoff ET, Ballester G, Zakka T, Bouhassira D, Teixeira MJ. Psychometric validation of the Portuguese version of the Neuropathic Pain Symptoms Inventory. Health Qual Life Outcomes. 2011 Nov 30;9:107. doi: 10.1186/1477-7525-9-107. PMID 22128801
- BACKGROUNDWen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.
- DERIVEDTer LI, Yamada AMTD, do Nascimento Martins Basilio A, Lopez RVM, Hsing WT. Acupuncture for peripheral neuropathy induced by paclitaxel in early-stage breast cancer: a randomized, parallel, controlled, blinded study in a Brazilian Oncologic Center (PACLILIN Study). Support Care Cancer. 2026 Jan 16;34(2):102. doi: 10.1007/s00520-026-10315-8.