Evidence map›Paper›PMID 26130292›Full record

Trial reportJournal of cancer survivorship : research and practice2016

A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy.

J A Lawrence, L Griffin, E P Balcueva, D L Groteluschen, T A Samuel, G J Lesser, M J Naughton, L D Case, E G Shaw, S R Rapp

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of cancer survivorship : research and practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04092647 (A Randomized Placebo-controlled Trial of Ashwagandha), which is not on this map. Cited by 51 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 5 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT04092647 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.

TypeinterventionalSponsorSutter HealthRan2023 to 2025Enrolled80ConditionsChemo FogArmsAshwagandha, Placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 5 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
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  8. Nicotinic treatment of post-chemotherapy subjective cognitive impairment: a pilot study.Journal of cancer survivorship : research and practice · 2019
    Trial
  9. Efficacy of Acupuncture Therapy for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Trial
  10. Review
  11. Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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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

10 authors at 4 institutions in 1 country.

J A LawrenceWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA. jalawren@wakehealth.edu.
L GriffinWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
E P BalcuevaMichigan CCOP, St. Mary's of Michigan, Saginaw, MI, 48602, USA.
D L GroteluschenSt. Vincent CCOP, Green Bay Oncology, Green Bay, WI, 54301, USA.
T A SamuelMedical College of Georgia MBCCOP, Augusta, GA, 30912, USA.
G J LesserWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
M J NaughtonWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
L D CaseWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
E G ShawWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
S R RappWake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
Wake Forest University · USAugusta University · USSt. Mary Mercy Livonia · USSt. Vincent Hospital · US

Funding

Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9M
Comprehensive Cancer Center of Wake Forest University CCOP Research BaseU10CA081851 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI SHAW, EDWARD G · 1999 to 2013
$22.0M
NCI NIH HHS 2U10CA081851NCI NIH HHS U10 CA081851NCI NIH HHS UG1 CA189824
6 · The paper itself

Abstract

purposeSome breast cancer survivors report cognitive difficulties greater than 1 year after chemotherapy. Acetylcholinesterase inhibitors (AChEI) may improve cognitive impairment. We conducted a randomized, placebo-controlled, pilot study to assess the feasibility of using the AChEI, donepezil, to improve subjective and objective measures of cognitive function in breast cancer survivors.

methodsWomen who received adjuvant chemotherapy 1-5 years prior with current cognitive dysfunction symptoms were randomized to 5 mg of donepezil/day vs placebo for 6 weeks and if tolerated 10 mg/day for 18 weeks for a total of 24 weeks. A battery of validated measures of attention, memory, language, visuomotor skills, processing speed, executive function, and motor dexterity and speed was administered at baseline and at 24 and 36 weeks. Subjective cognitive function, fatigue, sleep, mood, and health-related quality of life were evaluated at baseline and at 12, 24, and 36 weeks.

resultsSixty-two patients were enrolled, 76 % completed the study, self-reported compliance was 98 %, and toxicities were minimal. At the end of treatment, the donepezil group performed significantly better than the control group on two parameters of memory-the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall (p = 0.033) and HVLT-R Discrimination (p = 0.036). There were no significant differences on other cognitive variables or in subjective cognitive function or quality of life.

conclusionAccrual to this feasibility trial was robust, retention was good, compliance was excellent, and toxicities were minimal. IMPLICATIONS FOR CANCER SURVIVORS: Randomized clinical trials in breast cancer survivors to improve cognitive dysfunction are feasible. A phase III trial testing the efficacy of donepezil is warranted given these pilot results.

Indexed as

SurvivorsAdultAffectAgedBreast NeoplasmsChemotherapy, AdjuvantCholinesterase InhibitorsCognitionCognition DisordersDonepezilFatigueFeasibility StudiesFemaleHumansIndansMemoryCholinesterase InhibitorsDonepezilIndansPiperidinesBreast cancer survivorsCognitive dysfunctionDonepezilMemory

Identifiers

PMID26130292
PMCPMC4930878
OpenAlexW851240478

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.