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Trial record 1 of 1 for:    URCC-18007
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Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03996265
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : May 23, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Luke Peppone, University of Rochester NCORP Research Base

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Drug: Bupropion Hydrochloride Controlled-release Other: Placebo Administration Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Placebo Controlled Trial of Bupropion for Cancer Related Fatigue
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : October 13, 2024
Estimated Study Completion Date : March 24, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (bupropion hydrochloride controlled-release)
Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
 Drug: Bupropion Hydrochloride Controlled-release
Given PO
Other Names:
  • Bupropion HCl Controlled-release
  • Bupropion HCl Extended Release
  • Bupropion Hydrochloride Extended-Release
  • Forfivo XL
  • Wellbutrin SR
  • Wellbutrin XL
  • Zyban

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
 Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue [ Time Frame: At 12 weeks ]
    Measured by the Fatigue subscale of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Fatigue subscale (FFS). Will use analysis of covariance with group as the main factor and baseline FFS as a covariate.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: At 12 weeks ]
    Measured by the Total Score of the Functional Assessment Cancer Therapy - General scale (included in the FACIT-F). MPlus will be utilized to estimate the indirect (mediation) and direct effects and to obtain bootstrap-based 95% confidence intervals for these effects.

  2. Depression [ Time Frame: At 12 weeks ]
    Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8a. MPlus will be utilized to estimate the indirect (mediation) and direct effects and to obtain bootstrap based 95% confidence intervals for these effects.


Other Outcome Measures:
  1. Cognition [ Time Frame: At 12 weeks ]
    Measured by the PROMIS Cognitive Functioning 8a and Cognitive Abilities 4a measures. Will perform mediation analyses.

  2. Symptomatology [ Time Frame: At 12 weeks ]
    Measured by the M.D. Anderson Symptom Inventory.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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 an monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within two 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 psychiatric or neurological disorder(s) that would interfere with study participation per physician or physician's designee
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996265


Locations
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Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heather S Jim University of Rochester NCORP Research Base
More Information
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Responsible Party: Luke Peppone, Associate Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT03996265    
Other Study ID Numbers: URCC-18007
NCI-2019-01528 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC-18007 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-18007 ( Other Identifier: DCP )
URCC-18007 ( Other Identifier: CTEP )
R01CA214647 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors