Researchers seek postmenopausal women with hormone-positive breast cancer for a clinical trial exploring whether daily doses of an antidepressant lessens pain related to the use of hormonal therapies, when compared to women who take no pain medicines.
In this study, postmenopausal women are women who have not had their period for at least 12 months because of menopause or removal of the ovaries or uterus. Women who had their uterus removed and have 30 mIU/ML or higher of the hormone FSH in their blood are also considered menopausal.
Background and Goals
Duloxetine hydrochloride (Cymbalta), is an antidepressant sometimes given to people for chronic pain, pain that comes and goes over a long period of time. Some people also take it for neuropathy, or pain, numbness and tingling in the hands and feet caused by some medicines and diseases.
Hormonal therapies used to treat hormone receptor-positive breast cancer are known to cause aches and pains in the joints. Hormonal therapies include aromatase inhibitors, medicines that reduce estrogen production given to postmenopausal women.
The trial investigators want to see if duloxetine hydrochloride lessens pain in women who have joint pain from taking aromatase inhibitors. They will measure each woman’s average joint pain over time to see if it improves when duloxetine hydrochloride is added to their treatment.
Participants will be randomly assigned to one of two study groups:
- Duloxetine hydrochloride taken once a day for days 1 – 7, twice a day for days 8 – 84, and once a day for days 85 – 91
- Placebo, taken as above
Both duloxetine hydrochloride and the placebo are pills taken by mouth. A placebo is an inactive substance.
Before starting the trial medicine, each woman will complete the Brief Pain Inventory – Short Form (BPI-SF), a 5-minute survey that asks about pain level, how pain impacts everyday life, where the pain is located and how much pain relief you feel. This first survey will serve as a baseline to be compared to the same survey, taken at different points during the trial. In some cases, the trial doctors may ask you to complete other surveys as well.
You will also give a blood sample at baseline and a few times during treatment. These samples will be used to collect data for other studies of biomarkers and genetics.
You may be eligible to take part if you are a postmenopausal woman with hormone receptor-positive, early-stage breast cancer and you:
- Have already had mastectomy or lumpectomy and are recovered from surgery
- Do not have metastatic (stage IV) disease
- Are experiencing joint pain that started or worsened after you began treatment with an aromatase inhibitor (must have average pain of 4 according to BPI-SF, 7 days before joining)
- Aromatase inhibitors must be anastrozole (Arimidex), letrozole (Femara), or exemestane (Aromasin). Participants should have taken the medicine for at least 21 days, but not longer than 1 year, before joining the study.
- Are in generally good health
You may not be eligible if you:
- Have certain psychiatric conditions, such as schizophrenia, bipolar disorder, or seizure disorders
- Abused or were dependent on alcohol or drugs within 1 year of starting the study
- Have liver disease or late-stage kidney disease
- Have other pain concerns, like arthritis or lupus
- Have cancer involving the bone
This study is being held in 148 locations in the United States. For locations and contact information, visit clinicaltrials.gov.