Evidence map›Paper›PMID 22682875›Full record

Trial reportThe journal of supportive oncology2013

A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.

Glenn J Lesser, Doug Case, Nancy Stark, Susan Williford, Jeff Giguere, L Astrid Garino, Michelle J Naughton, Mara Z Vitolins, Mark O Lively, Edward G Shaw and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of supportive oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00096356 (A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients), which is not on this map. Cited by 39 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 7 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00096356 phase1completednot on this map

A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients

TypeinterventionalSponsorWake Forest University Health SciencesRan2004 to 2009Enrolled236ConditionsBreast Cancer, FatigueArmsCoQ10 & Vitamin E, Placebo & Vitamin E
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 7 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. 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
  2. Pooled it
  3. The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Cancer-Related Fatigue, Version 2.2015.Journal of the National Comprehensive Cancer Network : JNCCN · 2015
    Guideline
  8. Trial
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  11. Trial
  12. Review
  13. Article
  14. Article
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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

11 authors at 1 institution in 1 country.

Glenn J LesserDepartment of Internal Medicine, Section on Hematology and Oncology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA. glesser@wakehealth.edu
Doug Case
Nancy Stark
Susan Williford
Jeff Giguere
L Astrid Garino
Michelle J Naughton
Mara Z Vitolins
Mark O Lively
Edward G Shaw
Wake Forest University Community Clinical Oncology Program Research Base
Wake Forest University · US

Funding

Tumor Tissue CoreP30CA012197 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Ruben A. Mesa · 1985 to 2026
$55.4M
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 P30 CA012197NCI NIH HHS U10 CA081851NCI NIH HHS U10 CA81851
6 · The paper itself

Abstract

backgroundCoenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

objectivesWe performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

resultsBetween September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632).

conclusionsSupplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

Indexed as

Outcome Assessment, Health CareAdministration, OralAdultAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsDietary SupplementsDouble-Blind MethodFatigueFemaleFollow-Up StudiesHumansMiddle AgedPatient ParticipationPrognosisAntineoplastic Agentscoenzyme Q10UbiquinoneVitamins

Identifiers

PMID22682875
PMCPMC3501550
OpenAlexW1963612467

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.