Trial record 1 of 2 for:    S1202
Previous Study | Return to List | Next Study

S1202: Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in Pts W/Early-Stage Breast Cancer Receiving Hormone Therapy

This study is currently recruiting participants.
Verified September 2013 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01598298
First received: May 11, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Breast Cancer
Musculoskeletal Complications
Pain
Drug: duloxetine hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Reduction in average joint pain according to BPI-SF assessed up to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in worst joint pain according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reduction in pain interference according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 294
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders 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
  • 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598298

Contacts
Contact: Kimberly Kaberle 2106148808 ext 1022 kkaberle@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Show 148 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: N. Lynn Henry, MD, PhD University of Michigan Cancer Center
Study Chair: Anne F. Schott, MD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01598298     History of Changes
Other Study ID Numbers: S1202, S1202, U10CA037429, NCI-2012-01960
Study First Received: May 11, 2012
Last Updated: September 30, 2013
Health Authority: United States: Federal Government

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
Aromatase Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014