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Duloxetine Hydrochloride in Reducing Pain in Patients with Stage 0-III Breast Cancer and Chronic Pain

Trial Status: Active

This phase II trial studies how well duloxetine hydrochloride works in reducing pain in patients with stage 0-III breast cancer who have chronic pain after treatment. Duloxetine hydrochloride is a medicine that acts in the brain to change how patients feel pain, and may work better than regular pain medications for treating chronic pain. Studying how duloxetine hydrochloride works may help doctors learn more about why breast cancer survivors develop pain and find better ways to treat chronic pain.

Inclusion Criteria

  • Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment; all indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment; concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted
  • Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture
  • Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)
  • Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception
  • Willing to withdraw from selective serotonin reuptake inhibitors and tricyclic antidepressants prior to treatment initiation
  • Patients who are currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, Lyrica) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

  • Prior use of duloxetine or milnacipran
  • Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)
  • Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase (MAO) inhibitor within 14 days prior to registration
  • Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing
  • Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
  • Significant risk of suicide based on the investigator’s judgment
  • History or behavior that would, in the investigator’s judgment, prohibit compliance for the duration of the study
  • History of alcohol or other substance abuse or dependence within the year prior to registration
  • Known chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by Cockcroft-Gault equation
  • Uncontrolled narrow-angle glaucoma
  • Clinically significant coagulation disorder
  • History of seizure disorder
  • Pregnant or breast-feeding; urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain
  • Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules
  • Currently taking selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or tricyclic antidepressant (TCA) regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient’s treating psychiatrist to taper cases off these medications prior to study treatment)

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: N. Lynn Henry

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Saundra S. Buys

PRIMARY OBJECTIVE:

I. To assess breast cancer survivors with chronic pain for the presence and degree of pain centralization.

SECONDARY OBJECTIVE:

I. To identify predictors of response to the primarily centrally-acting analgesic duloxetine (duloxetine hydrochloride) in breast cancer survivors with chronic treatment-emergent pain.

OUTLINE:

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) for 7 weeks. Treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 7-14 days.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
Saundra S. Buys

  • Primary ID HCI94979
  • Secondary IDs NCI-2014-02204, HUM00075181, UMCC 2013‐044
  • Clinicaltrials.gov ID NCT01912612