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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Peripheral Neuropathy

Treatments: Behavioral: FACT/GOG-Ntx questionnaire; Behavioral: Neuropathic Pain Scale (NPS) questionnaire; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02364726

15-011

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Acupuncture

Experimental group

Description:

As part of routine clinical care, a chemotherapy nurse, research nurse, or physician will assess the patient's symptoms including CIPN based on the NCI-CTC 4.0 criteria to determine the grade of CIPN. Once these patients develop National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for the intervention phase of the study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients who consent to the intervention phase of the study will then be treated with weekly acupuncture until the end of chemotherapy. No concomitant anti-neuropathy medication will be permitted. Subjects will receive acupuncture in bilateral ear points: shen men, point zero, two additional auricular acupuncture point where electrodermal signal is detected and bilateral body acupuncture points: LI4, TE5, LI11, ST40, Ba Feng, Ba xie.

Treatment:

Procedure: Acupuncture

Behavioral: Neuropathic Pain Scale (NPS) questionnaire

Behavioral: FACT/GOG-Ntx questionnaire