Trial Information

A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors

OBJECTIVES:

Primary

- To determine if acupuncture can reduce aromatase inhibitor (AI)-associated
musculoskeletal symptom severity, in terms of function and pain, in woman with stage
0-III breast cancer.

Secondary

- To assess if acupuncture decreases oral analgesic use in these patients.

- To assess if acupuncture decreases the proportion of patients who change or discontinue
AI therapy.

- To assess if acupuncture improves menopausal symptoms, mood (i.e., depression or
anxiety), sleep quality and sleep disturbance, and overall quality of life of these
patients.

- To assess if acupuncture changes plasma concentrations of estrogens (i.e., E1, E2, and
E1S), cytokine profile, and beta endorphin.

OUTLINE: This is a multicenter study. Patients are stratified according to participation in
the aromatase inhibitor trial, "A Multicenter Randomized Clinical Trial Correlating the
Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With
Aromatase Polymorphism" (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I (control): Patients receive 8 weekly sessions of sham acupuncture treatment
comprising 20 minutes of a non-penetrating device consisting of a retractable needle
and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture
points. Patients may receive 4 free acupuncture sessions (not sham) after the 12-week
(previously 24-week) follow-up visit.

- Arm II (treatment): Patients receive 8 weekly sessions of acupuncture treatment
comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV
6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65.

Quality of life is assessed periodically to measure changes in symptoms that may be related
to hot flashes and estrogen deprivation (i.e., menopausal symptoms, mood [depression and
anxiety], sleep quality, and overall quality of life using the menopausal symptoms
checklist); the Hot Flash Related Daily Interference Scale (HFRDI) and the Hot Flash Daily
Diary; the Pittsburgh Sleep Quality Index (PSQI); the Center for Epidemiologic Studies
Depression Scale (CESD); the Hospital Anxiety and Depression Scale (HADS-A); and the
EuroQOL.

Patients complete questionnaires including the Health Assessment Questionnaire (HAQ) and
visual analog scales (VAS) to assess both pain and global health status at baseline, after 4
and 8 weeks of acupuncture or sham acupuncture, and at follow-up at 12 weeks (previously 24
weeks). The average amount of daily oral analgesic usage is assessed at weeks 0, 4, 8, and
12(previously 24).

Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for plasma concentrations of estrogen (i.e., estrone E1, estradiol E2, and estrone
sulfate E1S) via HPLC-MS/MS, level of 35 serum cytokines via addressable laser bead
immunoassay (ALBIA) or classical sandwich ELISA, cytokines and their soluble receptors via
classical sandwich ELISA techniques, and Beta-endorphin via competitive ELISA.

All patients are followed for 12 weeks(previously 24 weeks). Patients in arm I may be
followed for an additional 4 weeks if they choose to receive the free acupuncture sessions.