S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

Study Description

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Brief Summary:

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Musculoskeletal Complications; Pain	Drug: duloxetine hydrochloride; Other: placebo	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	299 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official 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
Study Start Date :	June 2013
Actual Primary Completion Date :	April 2017
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm I; Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.	Drug: duloxetine hydrochloride; Given PO; Other Name: NSC-744012
Placebo Comparator: Arm II; Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.	Other: placebo; Given PO

Outcome Measures

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Primary Outcome Measures :

1. Average Joint Pain According to BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]
   Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".

Secondary Outcome Measures :

1. Worst Joint Pain According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]
   Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
2. Pain Interference According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]
   Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".

Eligibility Criteria

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Ages Eligible for Study:	up to 120 Years (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

• Patients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
• Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery
• Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
• Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF) within 7 days prior to registration; patients must have an "average pain" of at least 4 on the BPI-SF

PATIENT CHARACTERISTICS:

• Patients must be post-menopausal, as defined by at least one of the following:

  • At least 12 months since the last menstrual period
  • Prior bilateral oophorectomy
  • Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post menopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration OR
  • Have been on LHRH agonist therapy for at least 3 months and estradiol levels drawn within 28 days prior to registration are consistent with the institutional normal values for post-menopausal state.
• Patients must have Zubrod performance status of 0-2
• Patients must have no known allergy or hypersensitivity to duloxetine or any of the inactive ingredients in the matching placebo

• Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:

  • Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
  • History of alcohol or other substance abuse or dependence within 365 days prior to registration
  • Chronic liver disease
  • End-stage renal disease
  • Uncontrolled narrow-angle glaucoma
  • Clinically significant coagulation disorder
• Creatinine clearance > 30 mL/min
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x upper limit of normal
• Total bilirubin within the upper limit of normal
• Patients must be able to complete study questionnaires in English or Spanish
• Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone
• Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• If patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration
• Concurrent bisphosphonate and trastuzumab therapies are allowed
• Patients should have recovered from all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy

• Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days, but no longer than 12 months, prior to registration and plans to continue for at least an additional 180 days after registration

  • Anastrozole (Arimidex®) 1 mg daily
  • Letrozole (Femara®) 2.5 mg daily
  • Exemestane (Aromasin®) 25 mg daily
• Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: treatment with phenothiazines, propafenone, flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14 days prior to registration; or current use of anticoagulation medication (e.g., heparin, warfarin)
• Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration; patients must not have taken duloxetine or milnacipran within 90 days prior to registration
• Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration

Contacts and Locations

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Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	N. Lynn Henry, MD, PhD	University of Michigan Cancer Center
Study Chair:	Anne F. Schott, MD	University of Michigan Cancer Center

  Study Documents (Full-Text)

Documents provided by Southwest Oncology Group:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] December 15, 2017

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT01598298 History of Changes
Other Study ID Numbers:	S1202; S1202 ( Other Identifier: SWOG ); U10CA037429 ( U.S. NIH Grant/Contract ); NCI-2012-01960 ( Other Identifier: NCI )
First Posted:	May 15, 2012
Results First Posted:	February 28, 2018
Last Update Posted:	April 2, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	https://swog.org/Visitors/Download/Policies/Policy43.pdf

Keywords provided by Southwest Oncology Group:

estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer	stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; pain; musculoskeletal complications

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Duloxetine Hydrochloride; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs; Dopamine Agents