Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Acupuncture Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acupuncture Therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive immune response as measured by cytokine levels	Investigators will collect prospective blood samples to test for for cytokine levels	3 years
Innate immune response as measured by cytokime levels	Investigators will collect prospective blood samples to test for cytokine levels	3 years

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Investigators: Principal Investigator: Rebecca Crane-Okada, MD, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: ACU-JOINT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No