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Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture Therapy
Sponsored by
Saint John's Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • John Wayne Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adaptive immune response as measured by cytokine levels
Investigators will collect prospective blood samples to test for for cytokine levels
Innate immune response as measured by cytokime levels
Investigators will collect prospective blood samples to test for cytokine levels

Full Information

First Posted
June 18, 2015
Last Updated
July 12, 2017
Sponsor
Saint John's Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02548637
Brief Title
Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain
Official Title
Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint John's Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators propose to investigate the effect of acupuncture on patients experiencing joint pain from aromatase inhibitor therapy. The investigators will serially measure patient's symptoms and track current medications, joint pain, daily activities, fatigue, and quality of life. The investigators will collect peripheral blood at baseline, weeks 4 and 7, one week after the last acupuncture treatment and 4 weeks after the last acupuncture treatment. The investigators will study the samples collected at the five predetermined time-points to test for immune parameters, such as the innate and adaptive immune responses, as well as the proliferative capabilities and pro-inflammatory mediators reflected in innate and adaptive functional immune responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Joint Pain tabulated from Joint Pain Assessment Questionnaire
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Adaptive immune response as measured by cytokine levels
Description
Investigators will collect prospective blood samples to test for for cytokine levels
Time Frame
3 years
Title
Innate immune response as measured by cytokime levels
Description
Investigators will collect prospective blood samples to test for cytokine levels
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Crane-Okada, MD
Organizational Affiliation
Saint John's Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

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