Acupuncture for treatment of joint pain secondary to aromatase inhibitor therapy in women with early breast cancer

Not Applicable

Recruiting

• Conditions: Arthralgia secondary to aromatase inhibitor; Breast Cancer; Cancer - Breast; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12611000149965
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Early breast cancer patients taking thrid generaion aromatase inhibitor.
Women with ongoing pain and/or stiffness in one or more joints which worsened after starting aromatase inhibitor.
Baseline worst pain score on BPI-SF of 3 or greater (scale 0-10)

Exclusion Criteria

Previous use of acupuncture for Aromatase Inhibitor induced joint paint
Severe concomitant illness or metastatic breast cancer
Severe coagulopathy or bleeding disorder or dermatological disease within the acupuncture area (including patients on warfarin or low molecular weight heparin).
Patients with cardiac pacemakers, defibrilator or any other implanted or topical electrical device.
Needle phobia rendering a patient unable to receive acupuncture.
Patients with intellectual or mental impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of acupuncture versus sham acupuncture. Benefit of acupuncture to reduce symptoms and pain associated with arthralgia related to adjuvant aromatase inhibitor therapy. Assessments will be measured by a research assistant blinded to the baseline measurements.To ensure a comprehensive evaluation of the patient's symptoms, both self report and a clinical examination will be utilised. Baseline self assessment will involve 4 short questionnaires: the BPI-SF, WOMAC, FACT-G and FACT-Cog which will collectively assess severity of pain, evaluate impact of pain on quality of life and determine social and emotional well being. Bloods to meausre markers of inflammation (ESR, CRP) will be performed before and after 6 weeks of treatment[End of acupuncture and 6 weeks post acupuncture]

Secondary Outcome Measures

Name	Time	Method
il[Nil]