Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer

NCT04461977 | Completed

• 1 other identifier: 26778919.3.0000.0072
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Peripheral Neuropathy Due to Chemotherapy

Keywords

Peripheral Neuropathy; Breast Cancer; Chemotherapy; Paclitaxel; Acupuncture

Outcome Measures

Primary Outcomes (1)

• The change the effects of neuropathic pain syndromes management from baseline

  Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.

  Screening visit (baseline), week 4, week 6, week 8, week 12

Secondary Outcomes (2)

• Baseline pain intensity change

  Screening visit (baseline), week 4, week 6, week 8, week 12

• Change in side effects associated with taxane treatments from baseline

  Screening visit (baseline), week 4, week 6, week 8, week 12

Study Arms (2)

A - true acupuncture

EXPERIMENTAL

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.

Other: True acupuncture

B - sham acupuncture

SHAM COMPARATOR

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.

Other: Sham acupuncture

Interventions

True acupuncture OTHER

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. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain "de qi" sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.

A - true acupuncture

Sham acupuncture OTHER

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. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.

B - sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)

São Paulo, São Paulo, 03102-006, Brazil

Location

Related Publications (7)

• Bouhassira 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 BACKGROUND

• Cella 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 BACKGROUND

• Jeong 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 BACKGROUND

• Bao 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 BACKGROUND

• de 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 BACKGROUND

• Wen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.

  BACKGROUND

• Ter 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.

  PMID: 41543601 DERIVED

Related Links

• Common Terminology Criteria for Adverse Events ( CTCAE ) version 5.0.

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lin I Ter, MD

  Instituto Brasileiro de Controle do Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham acupuncture
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: True acupuncture vs sham acupuncture

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: January 30, 2020
• Primary Completion: November 7, 2023
• Study Completion: March 26, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)