Hematopoietic and Lymphatic System NeoplasmPhase 3NCT03996265
Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors
A Phase 3 study testing Biospecimen Collection, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 542 sites in United States.
Trial summary
This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 542 sitesUnited States
- Study dates
- 27 Jun 2019to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Be diagnosed with cancer
- Have stable disease or no evidence of disease
- 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 systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) 2 or more months prior to enrollment. Participants currently receiving oral maintenance, targeted, or hormonal therapy are eligible. Participants receiving intravenous supportive therapy (e.g., bisphosphonates) are eligible
- 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
Who cannot join
- Be receiving intravenous anti-cancer therapy (e.g., intravenous immune checkpoint inhibitor therapy, targeted therapy)
- 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)
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- 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
Trial locations and contacts
542 sites in 1 country.
300 sites in 1 country
United States300 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
PCR Oncology
Arroyo Grande, California, 93420
Cone Health Cancer Center at Asheboro
Asheboro, North Carolina, 27203
Randolph Hospital
Asheboro, North Carolina, 27203
Cone Health MedCenter Asheboro
Asheboro, North Carolina, 27205
Northside Hospital
Atlanta, Georgia, 30342
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Rush - Copley Medical Center
Aurora, Illinois, 60504
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Woman's Hospital
Baton Rouge, Louisiana, 70817
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Bronson Battle Creek
Battle Creek, Michigan, 49017
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Overlake Medical Center
Bellevue, Washington, 98004
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Saint Charles Health System
Bend, Oregon, 97701
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Carle BroMenn Outpatient Center
Bloomington, Illinois, 61704
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Cox Cancer Center Branson
Branson, Missouri, 65616
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Cambridge Medical Center
Cambridge, Minnesota, 55008
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Caro Cancer Center
Caro, Michigan, 48723
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Saint Mary's Hospital
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Chelsea Hospital
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307
Carle at The Riverfront
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
Miami Valley Hospital North
Dayton, Ohio, 45415
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Kaiser Permanente-Franklin
Denver, Colorado, 80205
The Women's Imaging Center
Denver, Colorado, 80209
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Kaiser Permanente Dublin
Dublin, California, 94568
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Dublin Methodist Hospital
Dublin, Ohio, 43016
Northside Hospital - Duluth
Duluth, Georgia, 30096
Northwest Oncology LLC
Dyer, Indiana, 46311
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Henry Ford River District Hospital
East China, Michigan, 48054
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Providence Regional Cancer Partnership
Everett, Washington, 98201
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
Kaiser Permanente-Fremont
Fremont, California, 94538
Fresno Cancer Center
Fresno, California, 93720
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, 11740
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Wayne Hospital
Greenville, Ohio, 45331
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
Zangmeister Center Grove City
Grove City, Ohio, 43123
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
GenesisCare USA - Henderson
Henderson, Nevada, 89074
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Island Urology-Hilo
Hilo, Hawaii, 96720
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Saint Mary Medical Center
Hobart, Indiana, 46342
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Island Urology
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii, 96817
Kuakini Medical Center
Honolulu, Hawaii, 96817
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Oncology Center of The South Incorporated
Houma, Louisiana, 70360
Terrebonne General Medical Center
Houma, Louisiana, 70360
Centerpoint Medical Center LLC
Independence, Missouri, 64057
Saint Catherine Hospital
Indianapolis, Indiana, 46312
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
Straub Medical Center - Kahului Clinic
Kahului, Hawaii, 96732
Castle Medical Center
Kailua, Hawaii, 96734
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
Ascension Borgess Hospital
Kalamazoo, Michigan, 49048
Research Medical Center
Kansas City, Missouri, 64132
Ochsner Medical Center Kenner
Kenner, Louisiana, 70065
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Greater Dayton Cancer Center
Kettering, Ohio, 45409
First Dayton Cancer Care
Kettering, Ohio, 45420
Kettering Medical Center
Kettering, Ohio, 45429
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Kingman Regional Medical Center
Kingman, Arizona, 86401
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
Fairfield Medical Center
Lancaster, Ohio, 43130
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
Desert West Surgery
Las Vegas, Nevada, 89102
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
University Cancer Center
Las Vegas, Nevada, 89169
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, 66219
Minimally Invasive Surgery Hospital
Lenexa, Kansas, 66219
Beebe Medical Center
Lewes, Delaware, 19958
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Lewistown Hospital
Lewistown, Pennsylvania, 17044
About this study
Official title: Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. It belongs to the family of drugs called antidepressants and works by increasing certain types of activity in the brain. Bupropion may reduce cancer-related fatigue by causing changes in inflammation and stress hormones.
Read the detailed description
PRIMARY OBJECTIVE:
- 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 cancer survivors with fatigue.
SECONDARY OBJECTIVES:
- To assess the efficacy of bupropion versus placebo on depression and quality of life in cancer survivors with fatigue.
II. To assess the tolerability of bupropion in cancer survivors with fatigue.
EXPLORATORY OBJECTIVES:
- To assess the efficacy of bupropion versus placebo on symptomatology and cognition in 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. Patients also undergo blood sample collection throughout study.
ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.
- Being tested
- Biospecimen Collection, Bupropion Hydrochloride Controlled-release, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bupropion Hydrochloride Controlled-releaseDrug
Also called Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL
Given PO
Placebo AdministrationOther
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (bupropion hydrochloride controlled-release) | Experimental | Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study. Receives: Procedure: Biospecimen Collection; Drug: Bupropion Hydrochloride Controlled-release; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study. Receives: Procedure: Biospecimen Collection; Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured by 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.
Measured: At baseline and 12 weeks
Secondary outcomes (2)
Quality of life
Measured by the Total Score of the Functional Assessment Cancer Therapy - General (FACT-G) scale (included in the FACIT-F). The FACT-G consists of four subscales: physical well-being, functional well-being), emotional well-being, and social well-being. 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.
Measured: At baseline and 12 weeks
Depression
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8a. Will perform mediation analyses.
Measured: At baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start27 Jun 2019
- Primary completion30 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester NCORP Research Base
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester NCORP Research Base
- Investigators
- Heather S Jim, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996265
- Sponsor's protocol ID
- URCC-18007
- Other IDs
- NCI-2019-01528, URCC-18007, URCC-18007, URCC-18007, R01CA214647, UG1CA189961
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
- ClinicalTrials.gov ID
- NCT03996265
- Acronym / sponsor ID
- URCC-18007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- University of Rochester NCORP Research BaseUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. It belongs to the family of drugs called antidepressants and works by increasing certain types of activity in the brain. Bupropion may reduce cancer-related fatigue by causing changes in inflammation and stress hormones.
Detailed description
PRIMARY OBJECTIVE:
- 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 cancer survivors with fatigue.
SECONDARY OBJECTIVES:
- To assess the efficacy of bupropion versus placebo on depression and quality of life in cancer survivors with fatigue.
II. To assess the tolerability of bupropion in cancer survivors with fatigue.
EXPLORATORY OBJECTIVES:
- To assess the efficacy of bupropion versus placebo on symptomatology and cognition in 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. Patients also undergo blood sample collection throughout study.
ARM II: Patients receive placebo PO QD for up to 13 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (bupropion hydrochloride controlled-release) | Experimental | Procedure: Biospecimen Collection, Drug: Bupropion Hydrochloride Controlled-release, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study. |
| Arm II (placebo) | Placebo comparator | Procedure: Biospecimen Collection, Other: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age
- Be diagnosed with cancer
- Have stable disease or no evidence of disease
- 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 systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) 2 or more months prior to enrollment. Participants currently receiving oral maintenance, targeted, or hormonal therapy are eligible. Participants receiving intravenous supportive therapy (e.g., bisphosphonates) are eligible
Key exclusion criteria (11 listed)
- Be receiving intravenous anti-cancer therapy (e.g., intravenous immune checkpoint inhibitor therapy, targeted therapy)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (bupropion hydrochloride controlled-release), Arm II (placebo) |
| Bupropion Hydrochloride Controlled-releaseAlso: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XLGiven PO | Drug | Arm I (bupropion hydrochloride controlled-release) |
| Placebo AdministrationGiven PO | Other | Arm II (placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (bupropion hydrochloride controlled-release), Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (bupropion hydrochloride controlled-release), Arm II (placebo) |
Primary outcome
Fatigue
Time frame: At baseline and 12 weeks
Measured by 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.
2 secondary outcomes
Quality of life
Time frame: At baseline and 12 weeks
Depression
Time frame: At baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather S Jim principal investigator
University of Rochester NCORP Research Base
542 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biospecimen Collection, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 542 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 542 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: At baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.