Breast Cancer Clinical Trial
Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors
Summary
This phase III trial studies how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in breast cancer survivors.
Full Description
PRIMARY OBJECTIVES:
I. To determine the efficacy of bupropion hydrochloride controlled-release (bupropion) versus placebo in reducing fatigue in a double-blinded, placebo-controlled, randomized clinical trial of breast cancer survivors with fatigue.
SECONDARY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on depression and quality of life in breast cancer survivors with fatigue.
II. To assess the tolerability of bupropion in breast cancer survivors with fatigue.
EXPLORATORY OBJECTIVES:
I. To assess the efficacy of bupropion versus placebo on symptomatology and cognition in breast cancer survivors with fatigue.
II. To explore the effects of bupropion on putative mechanisms of cancer-related fatigue.
III. To explore associations of CYP2B6 genotype with bupropion metabolism and changes in fatigue.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive bupropion hydrochloride controlled-release orally (PO) once daily (QD) for up to 13 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of stage I-III breast cancer
Report worst level of fatigue in the past week as moderate to severe (i.e., a score >= 4 on a 0-10 scale, Screening Measures, question 1)
Have completed surgery, radiation, and/or chemotherapy, at least 2 or more months prior to enrollment (participants can be receiving maintenance, targeted or hormonal therapy)
Able to read and speak English
Currently not pregnant or breastfeeding. Women of child-bearing potential must agree to use adequate contraception, i.e, abstinence, IUD (intrauterine device), hormonal contraceptive (birth control pills) or barrier method (condoms) prior to study entry and for the duration of study participation
Be capable of providing written informed consent
Exclusion Criteria:
Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban
Be taking a monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within 2 weeks prior to enrollment
Be taking any anti-psychotic medications within a week prior to enrollment
Have a history of renal impairment (i.e., glomerular filtration rate < 45)
Have a history of cirrhosis (i.e., Child-Pugh score >= 5)
Have a history of seizures
Have a history of bulimia or anorexia nervosa
Report a history of sensitivity to bupropion
Report an allergy to lactose
Have a psychiatric or neurological disorder that would interfere with study participation per physician or physician's designee
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There are 93 Locations for this study
Newark Delaware, 19713, United States More Info
Principal Investigator
Wilmington Delaware, 19801, United States More Info
Macomb Illinois, 61455, United States More Info
Principal Investigator
Ottawa Illinois, 61350, United States More Info
Principal Investigator
Pekin Illinois, 61554, United States More Info
Principal Investigator
Peoria Illinois, 61615, United States More Info
Principal Investigator
Peoria Illinois, 61636, United States More Info
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Peru Illinois, 61354, United States More Info
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Peru Illinois, 61354, United States More Info
Principal Investigator
Princeton Illinois, 61356, United States More Info
Principal Investigator
Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62702, United States More Info
Principal Investigator
Springfield Illinois, 62781, United States More Info
Principal Investigator
Swansea Illinois, 62226, United States More Info
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Swansea Illinois, 62226, United States More Info
Principal Investigator
Ann Arbor Michigan, 48106, United States More Info
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Battle Creek Michigan, 49017, United States More Info
Principal Investigator
Brighton Michigan, 48114, United States More Info
Principal Investigator
Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Clarkston Michigan, 48346, United States More Info
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Clarkston Michigan, 48346, United States More Info
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Detroit Michigan, 48236, United States More Info
Principal Investigator
East China Township Michigan, 48054, United States More Info
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Flint Michigan, 48503, United States More Info
Principal Investigator
Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
Principal Investigator
Grand Rapids Michigan, 49503, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
Principal Investigator
Grosse Pointe Woods Michigan, 48236, United States More Info
Principal Investigator
Grosse Pointe Woods Michigan, 48236, United States More Info
Principal Investigator
Grosse Pointe Woods Michigan, 48236, United States More Info
Principal Investigator
Kalamazoo Michigan, 49007, United States More Info
Principal Investigator
Kalamazoo Michigan, 49007, United States More Info
Principal Investigator
Kalamazoo Michigan, 49048, United States More Info
Principal Investigator
Lansing Michigan, 48912, United States More Info
Principal Investigator
Livonia Michigan, 48154, United States More Info
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Livonia Michigan, 48154, United States More Info
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Macomb Michigan, 48044, United States More Info
Principal Investigator
Macomb Michigan, 48044, United States More Info
Principal Investigator
Marlette Michigan, 48453, United States More Info
Principal Investigator
Muskegon Michigan, 49444, United States More Info
Principal Investigator
Niles Michigan, 49120, United States More Info
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Pontiac Michigan, 48341, United States More Info
Principal Investigator
Pontiac Michigan, 48341, United States More Info
Principal Investigator
Pontiac Michigan, 48341, United States More Info
Principal Investigator
Pontiac Michigan, 48341, United States More Info
Principal Investigator
Reed City Michigan, 49677, United States More Info
Principal Investigator
Rochester Hills Michigan, 48309, United States More Info
Principal Investigator
Saginaw Michigan, 48601, United States More Info
Principal Investigator
Saginaw Michigan, 48604, United States More Info
Principal Investigator
Saint Joseph Michigan, 49085, United States More Info
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Saint Joseph Michigan, 49085, United States More Info
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Sterling Heights Michigan, 48312, United States More Info
Principal Investigator
Tawas City Michigan, 48764, United States More Info
Principal Investigator
Traverse City Michigan, 49684, United States More Info
Principal Investigator
Warren Michigan, 48088, United States More Info
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Warren Michigan, 48093, United States More Info
Principal Investigator
Warren Michigan, 48093, United States More Info
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Warren Michigan, 48093, United States More Info
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Warren Michigan, 48093, United States More Info
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West Branch Michigan, 48661, United States More Info
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Wyoming Michigan, 49519, United States More Info
Principal Investigator
Ypsilanti Michigan, 48106, United States More Info
Principal Investigator
Ypsilanti Michigan, 48197, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Cambridge Minnesota, 55008, United States More Info
Principal Investigator
Coon Rapids Minnesota, 55433, United States More Info
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Edina Minnesota, 55435, United States More Info
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Fridley Minnesota, 55432, United States More Info
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Maple Grove Minnesota, 55369, United States More Info
Principal Investigator
Maplewood Minnesota, 55109, United States More Info
Principal Investigator
Maplewood Minnesota, 55109, United States More Info
Principal Investigator
Minneapolis Minnesota, 55407, United States More Info
Principal Investigator
Minneapolis Minnesota, 55415, United States More Info
Principal Investigator
Minneapolis Minnesota, 55454, United States More Info
Principal Investigator
Monticello Minnesota, 55362, United States More Info
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New Ulm Minnesota, 56073, United States More Info
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Princeton Minnesota, 55371, United States More Info
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Robbinsdale Minnesota, 55422, United States More Info
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Saint Louis Park Minnesota, 55416, United States More Info
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Saint Paul Minnesota, 55101, United States More Info
Principal Investigator
Saint Paul Minnesota, 55102, United States More Info
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Shakopee Minnesota, 55379, United States More Info
Principal Investigator
Stillwater Minnesota, 55082, United States More Info
Principal Investigator
Waconia Minnesota, 55387, United States More Info
Principal Investigator
Willmar Minnesota, 56201, United States More Info
Principal Investigator
Woodbury Minnesota, 55125, United States More Info
Principal Investigator
Wyoming Minnesota, 55092, United States More Info
Principal Investigator
Bonne Terre Missouri, 63628, United States More Info
Principal Investigator
Cape Girardeau Missouri, 63703, United States More Info
Principal Investigator
Cape Girardeau Missouri, 63703, United States More Info
Principal Investigator
Jefferson City Missouri, 65109, United States More Info
Principal Investigator
Saint Louis Missouri, 63131, United States More Info
Principal Investigator
Sainte Genevieve Missouri, 63670, United States More Info
Principal Investigator
Sullivan Missouri, 63080, United States More Info
Principal Investigator
Sunset Hills Missouri, 63127, United States More Info
Principal Investigator
Winston-Salem North Carolina, 27104, United States More Info
Allentown Pennsylvania, 18103, United States More Info
Principal Investigator
Bethlehem Pennsylvania, 18017, United States More Info
Principal Investigator
Chadds Ford Pennsylvania, 19317, United States More Info
East Stroudsburg Pennsylvania, 18301, United States More Info
Principal Investigator
Hazleton Pennsylvania, 18201, United States More Info
Principal Investigator
Easley South Carolina, 29640, United States More Info
Principal Investigator
Greenville South Carolina, 29605, United States More Info
Principal Investigator
Greenville South Carolina, 29605, United States More Info
Principal Investigator
Greenville South Carolina, 29605, United States More Info
Principal Investigator
Greenville South Carolina, 29615, United States More Info
Principal Investigator
Greer South Carolina, 29650, United States More Info
Principal Investigator
Seneca South Carolina, 29672, United States More Info
Principal Investigator
Spartanburg South Carolina, 29307, United States More Info
Principal Investigator
Midlothian Virginia, 23114, United States More Info
Principal Investigator
Richmond Virginia, 23226, United States More Info
Principal Investigator
New Richmond Wisconsin, 54017, United States More Info
Principal Investigator
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