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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 : June 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date October 13, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
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). Scale scores range from 0-4; lower scores indicate greater fatigue. Will use analysis of covariance with group as the main factor and baseline FFS as a covariate.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
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.
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Quality of life (i.e., physical well-being, functional well-being, emotional well-being, and social well-being) [ Time Frame: At 12 weeks ]
    Measured by the Total Score of the Functional Assessment Cancer Therapy - General scale (included in the FACIT-F). The FACT-G consists of four subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. This will be utilized to estimate the indirect (mediation) and direct effects and to obtain bootstrap-based 95% confidence intervals for these effects.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2019)
  • Cognition [ Time Frame: At 12 weeks ]
    Measured by the PROMIS Cognitive Functioning 8a and Cognitive Abilities 4a measures. Will perform mediation analyses.
  • Symptomatology [ Time Frame: At 12 weeks ]
    Measured by the M.D. Anderson Symptom Inventory.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors
Official Title  ICMJE Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
  • Cancer Fatigue
  • Cancer Survivor
  • Complete Remission
  • 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
Intervention  ICMJE
  • 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: Placebo
    Given PO
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Bupropion Hydrochloride Controlled-release
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Other: Placebo
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
422
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 24, 2024
Estimated Primary Completion Date October 13, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Been diagnosed with stage I-III breast cancer
  • Be currently breast cancer-free
  • Report moderate to severe fatigue in the past week (i.e., a score >= 4 on a 0-10 scale, Screening Measures, question 1)
  • Attribute their fatigue to cancer and/or its treatment (Screening Measures, question 2)
  • Have completed surgery, radiation, standard dose chemotherapy, and/or targeted therapy 12-60 months previously (participants can be receiving hormonal therapy ? i.e., tamoxifen, anastrozole, letrozole, exemestane)
  • Able to read and speak English
  • 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:

  • Have another medical condition in which fatigue is a prominent symptom as documented in the medical chart (e.g., anemia, autoimmune disease, sleep apnea)
  • Be currently taking bupropion, Wellbutrin, Forfivo, Aplenzin, or Zyban (i.e., bupropion prescribed for other indications); an anti-depressant including but not limited to an monoamine oxidase inhibitor (MAOI), anti-psychotic, a systemic anti-TNF agent, linezolid, methylene blue, or a systemic corticosteroid (patients who have previously completed treatment with these agents at least one week prior and meet all other eligibility criteria are eligible to participate). Participants should be off an MAOI for at least 2 weeks prior to study entry
  • 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 (e.g., schizophrenia, alcohol use disorder) as documented in the medical chart or in the judgment of the provider or study staff
  • Be currently pregnant or breastfeeding or plan to become pregnant in the next four months, due to unknown teratogenicity of bupropion
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996265
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Morrow, University of Rochester NCORP Research Base
Study Sponsor  ICMJE Gary Morrow
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Heather S Jim University of Rochester NCORP Research Base
PRS Account University of Rochester
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP