NCT02129686

Brief Summary

This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2016

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

April 30, 2014

Last Update Submit

April 14, 2025

Conditions

Taxane-induced Peripheral NeuropathyChemotherapy-induced Peripheral Neuropathy (CIPN)Early-Stage Breast CarcinomaStage I Breast CancerStage II Breast CancerStage III Breast Cancer

Keywords

Chemotherapy-induced peripheral neuropathy (CIPN)AcupunctureEarly-Stage Breast CarcinomaStage I Breast CancerStage II Breast CancerStage III Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Response Rate from Baseline in PNQ Score

    The PNQ includes two questionnaire items: one asking about sensory neurotoxicity and the other asking about motor neurotoxicity. The questionnaire items correspond to the neurotoxicity questions included in the NCI-CTCAE. PNQ grades range from grade A (no neuropathy) to grade E (very severe neuropathy). Answer options will be coded 0=A to 4=E, with a higher score indicating more severe CIPN

    Baseline, Week 8

Secondary Outcomes (2)

  • Changes in FACT/NTX subscale baseline to 8 weeks

    Baseline, 8 Weeks

  • Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks

    Baseline, 8 Weeks

Study Arms (2)

Immediate Acupuncture Group

EXPERIMENTAL

Immediate acupuncture arm will receive acupuncture 3 times per week during week 1 and week 2, then 2 times per week from week 2 to week 8 for a total of 18 sessions. The crossover will take place after 8th week. The immediate acupuncture arm will enter a follow-up phase without acupuncture for 8 weeks from week 9 to week 16, while the standard usual care will be provided.

Procedure: Immediate Acupuncture Group

Delayed Acupuncture Group

ACTIVE COMPARATOR

The patients on the usual care/delayed acupuncture arm will continue their standard usual care with their physicians and care team. The crossover will take place after 8th week. After crossover, the patients initially on the usual care/delayed acupuncture arm will receive the identical acupuncture protocol but a less frequent schedule from week 9 to week 16: 2 times per week at week 9, then 1 time per week from week 10 to week 16 for a total of 9 sessions

Procedure: Delayed Acupuncture Group

Interventions

Immediate Acupuncture GroupPROCEDURE
Immediate Acupuncture Group
Delayed Acupuncture GroupPROCEDURE
Delayed Acupuncture Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of histologically or cytologically proven breast cancer at stage I, II and III, without evidence of distant metastasis;
  • Completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy
  • Reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) (Table 1 and the screening checklist);
  • Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12;
  • Age ≥ 18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Adequate hematological function: neutrophil count \>1.0 x109/L, platelet count \>50x109/L;
  • Signed informed consent.

You may not qualify if:

  • Patients with any of the following criteria will not be eligible for the study:
  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
  • Wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder;
  • History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, toxic neuropathy;
  • Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma;
  • Pregnancy or potential pregnancy and nursing;
  • Active clinically significant uncontrolled infection;
  • Prior use of acupuncture for CIPN within 6 months prior to study entry;
  • Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Lu W, Giobbie-Hurder A, Freedman RA, Shin IH, Lin NU, Partridge AH, Rosenthal DS, Ligibel JA. Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial. Oncologist. 2020 Apr;25(4):310-318. doi: 10.1634/theoncologist.2019-0489. Epub 2019 Oct 14.

    PMID: 32297442RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Weidong Lu, M.B., MPH, Ph.D

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

June 1, 2014

Primary Completion

September 15, 2016

Study Completion

June 1, 2021

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

US(1)