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

NCT ID: NCT02364726

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-09
• Study Completion Date: 2023-06-21

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.

Conditions

Breast Cancer; Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK.

Neuropathic Pain Scale (NPS) questionnaire

Intervention Type: BEHAVIORAL

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session.

FACT/GOG-Ntx questionnaire

Intervention Type: BEHAVIORAL

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion.

Interventions

Acupuncture

Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK.

Intervention Type: PROCEDURE

Neuropathic Pain Scale (NPS) questionnaire

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session.

Intervention Type: BEHAVIORAL

FACT/GOG-Ntx questionnaire

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ting Bao, MD, DABMA, MS

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-011

Identifier Type: -

Identifier Source: org_study_id