Clinical trial · Interventional
Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain
UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many women with breast cancer who are treated with aromatase inhibitor medications develop aches and pains during treatment, and some develop numbness and tingling in their hands and feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, pain medications do not work very well to relieve the pain. Duloxetine (Cymbalta) is a medication that was originally developed to treat depression. It has also been found to relieve pain that occurs in people with diabetes, fibromyalgia, arthritis, and other painful conditions. In this study we are testing to see if duloxetine will help treat the pain that can occur in women treated with aromatase inhibitors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duloxetine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Duloxetine
- interventionNames
- Drug: Duloxetine
Primary outcomes (1)
- measure
- Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.
- timeFrame
- 8 weeks
- description
- Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory \& reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.
Secondary outcomes (1)
- measure
- Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female; * Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab; * AI therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue; * AI-associated musculoskeletal symptoms, defined as: * Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or * Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy; * Average pain of ≥4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory; * ECOG performance status 0-2; * Willing and able to sign an informed consent document. Exclusion Criteria: * Known hypersensitivity to duloxetine or any of the inactive ingredients; * New musculoskeletal pain that is due specifically to fracture or traumatic injury; * Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment; * Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants; * Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder; * Chronic liver disease, end stage renal disease, or creatinine clearance \< 30 mL/min as defined by the Cockroft-Gault equation; * Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder; * Pregnant or breast feeding; * History of alcohol or other substance abuse or dependence within the year prior to enrollment; * Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
References
Publications (1)
- RESULTHenry NL, Banerjee M, Wicha M, Van Poznak C, Smerage JB, Schott AF, Griggs JJ, Hayes DF. Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms. Cancer. 2011 Dec 15;117(24):5469-75. doi: 10.1002/cncr.26230. Epub 2011 Jun 20. PMID 21692065