OHSU

IRB #

IRB00010502

Title

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer

Principal Investigator

Kathleen Kemmer

Study Purpose

To find out if duloxetine (cymbalta) decreases joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS).

Medical Condition(s)

Aromatase inhibitor-associated musculoskeletal syndrome (AIMSS).

Eligibility Criteria

1. Post-menopausal female with estrogen receptor (ER) and/or progesterone receptor (PgR) positive breast cancer with no evidence of metastatic disease
2. Must have recovered completely from either mastectomy or breast sparing surgery
3. Must be taking one the following drugs for at least 21 days before the study: Anastrozole (arimidex), letrozole (femara), or exemestane (aromasin)
4. Must have musculoskeletal symptoms that began after starting one of the drugs above.
5. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Study drug or placebo will be taken for 13 weeks. Follow-up visits will occur 1 and 11 weeks after the last dose of the study drug or placebo.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

SWOG

Recruitment End

04/30/2016

Compensation Provided

No


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