We need women throughout the United States with early-stage breast cancer who are taking a hormonal therapy—Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane)—for a research study evaluating whether acupuncture can help reduce joint pain and stiffness.
Hormonal therapy is used to treat postmenopausal women with hormone-sensitive breast cancer. Joint pain and stiffness is one of the most common side effects associated with these drugs. Acupuncture is a traditional Chinese medical treatment during which thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can reduce knee and back pain. This study is looking at whether acupuncture can also reduce joint pain caused by hormonal therapy for breast cancer.
Please read on to learn more about what’s involved and who can participate. If this study isn’t right for you, please pass it on to someone you know who is experiencing joint pain from hormonal therapy for breast cancer!
What's the study about?
The purpose of this study is to test whether 12-weeks of acupuncture can help reduce joint pain or stiffness caused by hormonal therapy for breast cancer.
The researchers need to enroll 228 women in this study.
If you sign up for the study “Acupuncture for Joint Symptoms in Women with Early Stage Breast Cancer," you will be asked to contact the participating clinical site closest to you. You will receive contact information for the sites after you RSVP. The participating site will conduct additional screening procedures to confirm that you are eligible. These procedures include:
• Medical history and physical exam
• Complete a questionnaire that will ask you to rate joint pain and stiffness
• Blood work to check your menopausal status (if necessary)
If you appear to be eligible and choose to participate in the study, you will be asked to participate in the following procedures at the site:
• Sign and initial the consent form.
• Be randomly assigned (like the flip of a coin) to participate in one of the three 12-week intervention groups:
- True acupuncture group – acupuncture twice weekly for 6 weeks (12 sessions), then weekly for 6 weeks (6 sessions).
- Sham acupuncture group –superficial needling at non-acupuncture points twice weekly for 6 weeks (12 sessions), then weekly for 6 weeks (6 sessions).
- Control group – usual care for 12 weeks.
If you are assigned to an acupuncture group, you will not be told whether you are receiving either true or sham acupuncture. Only the acupuncturist will be aware of the acupuncture assignment.
• Go to the study site for the baseline visit, and then again at weeks 6, 12, 24, and 52. At these visits, you will be asked to have the following tests and procedures:
- Complete questionnaires that ask about how you are feeling during your treatment and how you are performing in your daily activities. You will also be asked to rate your joint pain and stiffness, and respond to questions regarding aromatase inhibitors and pain medications.
- Functional testing for hand grip strength and a short walking test.
- Provide blood and urine samples.
• Participate in a telephone interview at weeks 2,4,16, and 20 to record your acupuncture schedule (if applicable), side effects, and pain treatments you are receiving.
After the 24-week visit, ALL participants will be offered a voucher for ten free true acupuncture sessions to be used off-study at your convenience.
Who is conducting the study?
Southwest Oncology Group (SWOG). SWOG is one of the five cooperative groups that together comprise the National Cancer Institute’s National Clinical Trials Network. SWOG designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. Learn more here: http://www.swog.org/Visitors/AboutUs.asp
The study is being conducted at multiple sites throughout the United States. Participating clinics are located in the following cities:
• Columbia University, New York, NY
• Fred Hutchinson Cancer Center, Seattle, WA
• Grand Rapids Community Cancer Program, Grand Rapids, MI
• Greenville Community Cancer Program, Greenville, SC
• Huntsman Cancer Institute, Salt Lake City, UT
• Kaiser Permanente, Vallejo, Walnut Creek, and San Francisco, CA
• Lahey Hospital and Medical Center, Burlington, MA
• Good Samaritan Hospital, Portland, OR
• St. Luke’s Mountain States, Boise, ID
Who can participate?
You can join the study “Acupuncture for Joint Symptoms in Women with Early Stage Breast Cancer” if you match ALL of these MAIN categories:
• You are a woman with stage I, II, or III breast cancer with no evidence of metastatic disease.
• You are postmenopausal.
• You are currently taking hormonal therapy (anastrozole, letrozole, or exemestane) and have taken it for at least 30 days.
• You plan to continue taking the hormonal therapy (anastrozole, letrozole, or exemestane) for at least one year.
• You have joint pain or stiffness that started or increased since starting hormonal therapy for breast cancer.
• You have NOT had prior acupuncture treatment for joint symptoms at any time.
• You live near or are able to travel (at your own expense) to one of the study sites.
Please note that these are only the MAIN eligibility criteria and the research team will need to review your medical records and ask additional questions to determine if you are eligible for the clinical trial. After you RSVP, you will be asked to contact the participating study site nearest you