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

Peripheral Neuropathy Due to Chemotherapy Clinical Trial

Official title:

Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461977
• Other study ID #: 26778919.3.0000.0072
• Status: Completed
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: March 26, 2024

Study information

• Verified date: May 2024
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be randomized to receive true acupuncture (intervention group) vs sham acupuncture (control), once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003) questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week 6, week 8 and week 12. The study has duration of 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 26, 2024
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy Due to Chemotherapy

Intervention

Other:
• True acupuncture
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.
• Sham acupuncture
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.

Locations

Country	Name	City	State
Brazil	Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline pain intensity change	Visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).	Screening visit (baseline), week 4, week 6, week 8, week 12
Secondary	Change in side effects associated with taxane treatments from baseline	FACT-taxane questionnaire. It is a self-report instrument that was developed to measure the health-related Quality of life of patients receiving taxane-containing chemotherapy. This scale has 16 items, including an 11-item neurotoxicity subscale and five additional taxane-specific questions related to the effects of arthralgia, myalgia, and skin changes. The total score is calculated as the sum of the un-weighted subscale score.	Screening visit (baseline), week 4, week 6, week 8, week 12

External Links

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