Evidence map›Paper›PMID 37847317›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2023

A pilot randomized, placebo-controlled, double-blind study of omega-3 fatty acids to prevent paclitaxel-associated acute pain syndrome in breast cancer patients: Alliance A22_Pilot2.

Bernard Tawfik, Zoneddy R Dayao, Ursa Abigail Brown-Glaberman, V Shane Pankratz, Jacqueline M Lafky, Charles L Loprinzi, Debra L Barton

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01821833 (A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT01821833 nacompletednot on this map

A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome

TypeinterventionalSponsorNew Mexico Cancer Research AllianceRan2016 to 2022Enrolled60ConditionsBreast Cancer, Ovarian Neoplasm, PainArmsOmega-3 fatty acid, Placebo, Paclitaxel
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Trial
  3. Food groups and micronutrients associated with chemotherapy-induced peripheral neuropathy in survivors of cancer post-neurotoxic treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. 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

7 authors at 4 institutions in 1 country.

Bernard TawfikUNM Comprehensive Cancer Center, Division of Hematology/Oncology, MSC 07-4025, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA. BTawfik@salud.unm.edu.ORCID https://orcid.org/0000-0002-4380-2471
Zoneddy R DayaoUNM Comprehensive Cancer Center, Division of Hematology/Oncology, MSC 07-4025, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA.
Ursa Abigail Brown-GlabermanUNM Comprehensive Cancer Center, Division of Hematology/Oncology, MSC 07-4025, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA.
V Shane PankratzUNM Comprehensive Cancer Center, Division of Hematology/Oncology, MSC 07-4025, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA.
Jacqueline M LafkyAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
Charles L LoprinziMayo Clinic, Rochester, MN, USA.
Debra L BartonUniversity of Tennessee, Knoxville, TN, USA.
University of New Mexico · USMayo Clinic · USMayo Clinic in Arizona · USUniversity of Tennessee at Knoxville · US

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
WOMEN'S CANCERS RESEARCH PROGRAMP30CA118100 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Yolanda Sanchez · 2005 to 2026
$57.1M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI NIH HHS P30 CA118100NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA232760
6 · The paper itself

Abstract

purposePaclitaxel is associated with an acute pain syndrome (P-APS- and chronic chemotherapy-induced peripheral neuropathy (CIPN). P-APS is associated with higher risk of CIPN. Omega-3 fatty acids have well-established anti-inflammatory and neuroprotective properties. The primary purpose of this pilot study was to assess whether omega-3 fatty acids could decrease P-APS and thus CIPN.

methodsPatients scheduled to receive weekly paclitaxel for breast cancer were randomized to receive 4 g of omega-3 acid ethyl esters (Lovaza) or placebo, beginning 1 week prior and continued until paclitaxel was stopped. Patients completed acute pain questionnaires at baseline, daily after each treatment, and 1 month after completion of therapy.

resultsSixty patients (49 evaluable) were randomized to treatment versus placebo. Seventeen (68.0%) patients receiving the omega-3 fatty acids intervention experienced P-APS, compared to 15 (62.5%) of those receiving placebo during the first week of treatment (p = 0.77). Over the full 12-week study, 21 (84.0%) patients receiving the omega-3 fatty acid intervention experienced P-APS, compared to 21 (87.5%) of those receiving placebo (p = 1.0). Secondary outcomes suggested that those in the intervention arm used more over-the-counter analgesics (OR: 1.65, 95% CI: 0.72-3.78, p = 0.23), used more opiates (OR: 2.06, 95% CI: 0.55-7.75, p = 0.28), and experienced higher levels of CIPN (12.8, 95% CI: 7.6-19.4 vs. 8.4, 95% CI: 4.6-13.2, p = 0.21).

conclusionsThe results of this pilot study do not support further study of the use of omega-3 fatty acids for the prevention of the P-APS and CIPN.

trial registrationNumber: NCT01821833.

Indexed as

Acute PainBreast NeoplasmsFatty Acids, Omega-3Peripheral Nervous System DiseasesDouble-Blind MethodFemaleHumansPaclitaxelPilot ProjectsFatty Acids, Omega-3PaclitaxelBreast cancerChronic chemotherapy-induced peripheral neuropathy (CIPN)Omega-3 fatty acidsPaclitaxelPaclitaxel acute pain syndrome

Identifiers

PMID37847317
PMCPMC10642207
OpenAlexW4387692534

What OpenQuestion holds

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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.