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NCT Number: NCT02364726

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peripheral Neuropathy Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Westchester, Harrison, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

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

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

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.

Primary outcomes

  1. CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0

    Time frame: 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 outcomes

  1. CIPN severity as measured by FACT/GOG-Nts

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2015
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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