NCT02548637

Brief Summary

Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in pain happens by lowering inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

June 18, 2015

Last Update Submit

July 12, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Joint Pain tabulated from Joint Pain Assessment Questionnaire

    Investigators will serially measure joint pain symptoms using questionnaires administered at pre-determined time points. A summary of pain scores will be tabulated for all visits.

    3 years

Secondary Outcomes (2)

  • Adaptive immune response as measured by cytokine levels

    3 years

  • Innate immune response as measured by cytokime levels

    3 years

Study Arms (1)

Acupuncture Therapy

EXPERIMENTAL

Based on the Traditional Chinese Medicine theory, investigators will use the systemic treatment methods (full body treatment with the joint specifications). Every patient will receive the standard protocols of these points uniformly regardless of their symptoms. The only variable will be the location of placement of the four electrodes (two positive charges and two negative charges) to the needle points at the most painful joints bilaterally. Needles will be in place a total of 45 minutes per session. The Thermal Design Power (TDP) infrared heat lamp will be applied concurrently to the most painful joint(s) for the entire 45 minutes. Acupuncture will be administered twice a week for 6 weeks, then once a week for an additional 4 weeks.

Procedure: Acupuncture Therapy

Interventions

Acupuncture TherapyPROCEDURE

The standard textbook of Chinese Acupuncture and Moxibustion is the source for the name and location of the points for this study. A total of 38 points will be used, divided between two acupuncture sessions: 20 points or 37 locations in the supine position; 18 points or 36 locations in the prone position. Other than points governing vessel (GV) 20, conception vessel (CV) 6, CV 10, all points will be performed bilaterally.

Acupuncture Therapy

Eligibility Criteria

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

You may qualify if:

  • Female
  • Must be on aromatase inhibitor therapy continuously for breast cancer treatment for at least the preceding two months
  • Must have experienced increased or new onset joint pain daily to a degree equal to or greater than 4 on a pain scale of 0-10 after starting aromatase inhibitor therapy
  • Able to read and write English
  • Able to give written informed consent to participate in the study

You may not qualify if:

  • Have a known autoimmune disease or acute infection
  • Have had acupuncture treatment within 6 months of study enrollment
  • Known needle phobia
  • Known metal allergies
  • Have an implantable device, such as pacemaker, defibrillator or other device contraindicated with electrical stimulation
  • Use of nonsteroidal antiinflammatory drugs (NSAIDs) or narcotics within 7 days of study enrollment and during study period (15 weeks)
  • Receipt of prior chemotherapy, immunotherapy or radiation therapy within 90 days
  • On anticoagulant therapy
  • Receiving physical or occupational therapy concurrently
  • Taking herbs or herbal teas within 7 days of study enrollment and during study period (15 weeks)
  • Have an immune-compromising medical condition or currently receiving immune-modulating therapies (including corticosteroids)
  • Enrolled in any other active cancer treatment protocols
  • Bone fracture or surgery of an affected extremity within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Rebecca Crane-Okada, MD

    Saint John's Cancer Institute

    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

June 18, 2015

First Posted

September 14, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)