Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

Breast Cancer Clinical Trial

Official title:

Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548637
• Other study ID #: ACU-JOINT001
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: July 12, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
John Wayne Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adaptive immune response as measured by cytokine levels	Investigators will collect prospective blood samples to test for for cytokine levels	3 years
Secondary	Innate immune response as measured by cytokime levels	Investigators will collect prospective blood samples to test for cytokine levels	3 years