NCT02364726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

8.4 years

First QC Date

February 10, 2015

Last Update Submit

June 21, 2023

Conditions

Breast CancerPeripheral Neuropathy

Keywords

AcupuncturePaclitaxel15-011

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Secondary Outcomes (1)

  • CIPN severity as measured by FACT/GOG-Nts

    2 years

Study Arms (1)

Acupuncture

EXPERIMENTAL

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.

Procedure: AcupunctureBehavioral: Neuropathic Pain Scale (NPS) questionnaireBehavioral: FACT/GOG-Ntx questionnaire

Interventions

AcupuncturePROCEDURE

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.

Acupuncture
Neuropathic Pain Scale (NPS) questionnaireBEHAVIORAL

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.

Acupuncture
FACT/GOG-Ntx questionnaireBEHAVIORAL

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.

Acupuncture

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsPeripheral Nervous System Diseases

Interventions

Acupuncture TherapySurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ting Bao, MD, DABMA, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

February 9, 2015

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(2)