NCT01050075

Brief Summary

RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

Status
terminated

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

January 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

January 14, 2010

Last Update Submit

November 2, 2017

Conditions

Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Keywords

male breast cancerneurotoxicityrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Change in the Neuropathic Pain Symptom Inventory Scores

    At the end of 4 courses of chemotherapy

Secondary Outcomes (5)

  • Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management

    Eight weeks after study enrollment

  • Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment

    Eight weeks after study enrollment

  • Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture

    Eight weeks after study enrollment

  • Comparison of changes in neurological assessment of patients

    At the end of therapy and 1 month after the end of therapy

  • Correlation between nerve inventory questionnaires and quantitative nerve tests

    Eight weeks after study enrollment

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.

Other: acupuncture therapyOther: questionnaire administrationOther: management of therapy complications

Arm II

EXPERIMENTAL

Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.

Other: acupuncture therapyOther: questionnaire administrationOther: management of therapy complications

Interventions

acupuncture therapyOTHER

acupuncture therapy

Also known as: acupuncture
Arm IArm II
questionnaire administrationOTHER

Ancillary study

Arm IArm II
management of therapy complicationsOTHER

To be determined by the treating physician

Also known as: complications of therapy, management of
Arm IArm II

Eligibility Criteria

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

You may qualify if:

  • Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
  • Performance ECOG 0-2 (Karnofsky Performance Status \>= 60%)
  • Life expectancy of greater than 6 months
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Patients with radiologically confirmed stage IV breast cancer
  • Patients who had acupuncture in the previous 8 weeks
  • Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
  • Patients with needle phobia
  • Patients who experienced any peripheral neuropathy prior to chemotherapy
  • Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
  • Patients with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

Location

City of Hope Medical Group Inc

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, MaleNeurotoxicity Syndromes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Harry Openshaw

    City of Hope Medical Center

    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
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(2)