Evidence map›Paper›PMID 32147571›Full record

ArticleContemporary clinical trials2020

A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.

Heather S L Jim, Aasha I Hoogland, Hyo Sook Han, Eva Culakova, Charles Heckler, Michelle Janelsins, Geoffrey C Williams, Julienne Bower, Stephen Cole, Zeruesenay Desta and 3 more

Open access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Heather S L JimMoffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.
Aasha I HooglandMoffitt Cancer Center, Tampa, FL, USA.
Hyo Sook HanMoffitt Cancer Center, Tampa, FL, USA.
Eva CulakovaUniversity of Rochester Medical Center, Rochester, NY, USA.
Charles HecklerUniversity of Rochester Medical Center, Rochester, NY, USA.
Michelle JanelsinsUniversity of Rochester Medical Center, Rochester, NY, USA.
Geoffrey C WilliamsUniversity of Rochester Medical Center, Rochester, NY, USA.
Julienne BowerUniversity of California Los Angeles, Los Angeles, CA, USA.
Stephen ColeUniversity of California Los Angeles, Los Angeles, CA, USA.
Zeruesenay DestaIndiana University School of Medicine, Indianapolis, IN, USA.
Margarita Bobonis BabiloniaMoffitt Cancer Center, Tampa, FL, USA.
Gary MorrowUniversity of Rochester Medical Center, Rochester, NY, USA.
Luke PepponeUniversity of Rochester Medical Center, Rochester, NY, USA.
University of Rochester Medical Center · USMoffitt Cancer Center · USUniversity of California, Los Angeles · USIndiana University School of Medicine

Funding

TRANSCRIPTIONAL PROFILINGP30CA072720 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Tracie Saunders · 1997 to 2026
$94.5M
TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Randomized Placebo Controlled Trial of Bupropion for Cancer Related FatigueR01CA214647 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI JIM, HEATHER S.L. · 2018 to 2022
$3.0M
Developing a Culturally Targeted mHealth Intervention for Cancer-Related Sleep Disturbance in African American Breast Cancer SurvivorsK01CA211789 · NCI · RBHS -CANCER INSTITUTE OF NEW JERSEY · PI GONZALEZ, BRIAN D · 2016 to 2019
$585k
NCI NIH HHS K01 CA211789NCI NIH HHS P30 CA072720NCI NIH HHS P30 CA076292NCI NIH HHS R01 CA214647NCI NIH HHS UG1 CA189961
6 · The paper itself

Abstract

backgroundCancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.

methodsA randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored. DISCUSSION: This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.

Indexed as

Cancer SurvivorsAge FactorsAntidepressive Agents, Second-GenerationBreast NeoplasmsBupropionCytochrome P-450 CYP2B6Delayed-Action PreparationsDepressionDouble-Blind MethodFatigueFemaleHealth BehaviorHumansMenopauseQuality of LifeRandomized Controlled Trials as Topic2-(nitrooxy)ethyl apovincaminateAntidepressive Agents, Second-GenerationBupropionCYP2B6 protein, humanCytochrome P-450 CYP2B6Delayed-Action PreparationsVinca AlkaloidsBreast cancerBupropionFatigueProtocolRandomized controlled trial

Identifiers

PMID32147571
PMCPMC7263969
OpenAlexW3011247932

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.