Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer; Peripheral Neuropathy

• Registration Number: NCT02364726
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study the investigators will assess if acupuncture can be used to ease the pain, tingling and numbness that may be caused by chemotherapy and improve quality of life during chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-09
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Status Verified: 2023-06
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Screening Phase:

• Age 21 or older.
• Histologically proven stage I-III carcinoma of the breast.
• Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel.
• Eastern Cooperative Oncology Group performance status 0-2 (see Appendix B).
• The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
• Proficiency in English with the ability to speak and read English.

Exclusion Criteria

• Known metastatic (stage IV) breast cancer involvement.
• Pre-existing peripheral neuropathy within 28 days of screening consent
• Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.

Intervention Phase:

• Age 21 or older.
• Histologically proven stage I-III carcinoma of the breast.
• Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane.
• Eastern Cooperative Oncology Group performance status 0-2
• The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
• Proficiency in English with the ability to speak and read English
• While on neurotoxic chemotherapy, has developed NCI-CTC grade 2 CIPN

Exclusion Criteria:

• Known metastatic (stage IV) breast cancer involvement.
• Pre-existing peripheral neuropathy within 28 days of screening consent.
• Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0	1 year	After the initiation of acupuncture through the end of chemotherapy in breast cancer patients undergoing neoadjuvant or adjuvant weekly paclitaxel chemotherapy when compared to historical control ECOG study 1199 \[1\] weekly paclitaxel treatment arm. The efficacy of acupuncture in reducing CIPN severity and preventing progression of grade 2 CIPN to grade 3 or higher.

Secondary Outcome Measures

Name	Time	Method
CIPN severity as measured by FACT/GOG-Nts	2 years	Validated patient-reported outcome questionnaires: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire, the Neuropathy Pain Scale (NPS) and the vibration sensation test will be assessed at the time of intervention consent and then after the last acupuncture session on the same day of the last chemotherapy. CIPN grade per NCI-CTC 4.0 will be assessed weekly and then once again at 3 months (+/-2 weeks) after chemotherapy completion .

Trial Locations

Locations (2)

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States