Clinical Trials

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

Contact Information: email HopkinsBreastTrials@jhmi.edu

Purpose: This research is being done to find out if acupuncture can ease or reduce the joint and/or muscle discomfort experienced from taking aromatase inhibitors (AIs).

Eligibility: Breast cancer patients taking aromatase inhibitors, which include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara) who have never had acupuncture before and are experiencing joint stiffness or pain that is thought to be due to the AI may join this study.

Study Overview / Treatment: You will be asked to sign a consent form and answer questions to make sure that you are healthy and eligible to take part in the trial. You will then be randomly assigned to one of two groups. You, your doctors and nurses will not know which group you are in. Only the acupuncture practitioner will know which group you are in. Subjects in Group 1 will have actual acupuncture done. Subjects in Group 2 will receive sham acupuncture, a procedure on the skin that will feel like acupuncture but it is not an actual acupuncture. You will come to the clinic once a week for 8 weeks, and then you will have a follow-up visit after about 6 months. You will receive acupuncture or sham acupuncture during your weekly visits. Women in both groups will have a sample of blood taken to check hormone levels specifically for the study (on the 1st and 8th visits). You will also be asked to complete questionnaires about overall health and well being (on the 1st, 4th, 8th and final visits) and daily diaries looking at hot flashes, medications, and problems. At the final visit you will find out which group you were in. Participants in the sham acupuncture group will be offered 4 weekly acupuncture treatments for free after the last follow-up visit.

Principal Investigators:
Dr. Ting Bao, University of Maryland Department of Oncology Dr. Vered Stearns, Johns Hopkins University School of Medicine, Department of Oncology