Trial Information

Acupuncture and Aromatase Inhibitor Related Arthralgia

PRIMARY OBJECTIVES:

I. To determine the overall effect of acupuncture for reducing arthralgia among breast
cancer survivors (BCS) receiving AIs.

II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS
receiving AIs.

III. To elucidate the relationship between response expectancy measured by the Acupuncture
Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of
BPI pain severity score at the end of intervention.

SECONDARY OBJECTIVES:

I. To explore the effects of acupuncture on other common symptoms including fatigue,
insomnia, and psychological distress among BCS who experience joint pain.

II. To determine the correlation among pain and fatigue, insomnia, and psychological
distress using previously validated instruments.

III. To explore the effects of acupuncture on quality of life among BCS who experience joint
pain.

IV. To explore the effect of acupuncture on objective measure of sleep and activity.

V. To identify potential genetic determinants to response to acupuncture.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks
(twice weekly for 2 weeks and 6 weekly treatments).

ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments
over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at
non-acupuncture points.

ARM III (Control): Wait-list control patients are contacted by phone at the same frequency
as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

After completion of study treatment, patients are followed at 4 weeks.