Clinical trial NCT04461977: Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer
Official title: Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy Due to Chemotherapy
Keywords: Peripheral Neuropathy
Breast Cancer
Chemotherapy
Paclitaxel
Acupuncture
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: True acupuncture vs sham acupuncture
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change the effects of neuropathic pain syndromes management from baseline
timeFrame: Screening visit (baseline), week 4, week 6, week 8, week 12
Secondary outcomes:
measure: Baseline pain intensity change
timeFrame: Screening visit (baseline), week 4, week 6, week 8, week 12
measure: Change in side effects associated with taxane treatments from baseline
timeFrame: Screening visit (baseline), week 4, week 6, week 8, week 12
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)
state: SP
Study officials:
affiliation: Instituto Brasileiro de Controle do Cancer
name: Lin I Ter, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
citation: Wen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.