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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

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Abstract

Purpose

Paclitaxel 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.

Methods

Patients 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.

Results

Sixty 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).

Conclusions

The 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 registration

Number: NCT01821833

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Funding

Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under the Award Number UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant), UG1CA232760, and partially supported by the UNM Comprehensive Cancer Center Support Grant NCI P30CA118100, and the Biostatistics shared resource. https://acknowledgments.alliancefound.org.

Author information

Authors and Affiliations

  1. UNM Comprehensive Cancer Center, Division of Hematology/Oncology, MSC 07-4025, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA

    Bernard Tawfik, Zoneddy R. Dayao, Ursa Abigail Brown-Glaberman & V. Shane Pankratz

  2. School of Medicine, University of New Mexico, Albuquerque, NM, USA

    Bernard Tawfik, Zoneddy R. Dayao, Ursa Abigail Brown-Glaberman & V. Shane Pankratz

  3. Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA

    Jacqueline M. Lafky

  4. Mayo Clinic, Rochester, MN, USA

    Charles L. Loprinzi

  5. University of Tennessee, Knoxville, TN, USA

    Debra L. Barton

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Contributions

Z.D., J.L., L.C., and D.B. conceived the initial trial design. V.P. performed data analysis and prepared figures and tables. B.T. wrote the manuscript with significant edits from U.B. All authors reviewed the manuscript.

Corresponding author

Correspondence to Bernard Tawfik.

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Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki. This study was approved by the University of New Mexico Health Sciences Center Institutional Review Board [UNM HRPO] (#19-562) and monitored by the Data Safety Monitoring Board.

Informed consent

Was obtained from all individual participants included in the study.

Competing interests

The authors declare no competing interests.

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Tawfik, B., Dayao, Z.R., Brown-Glaberman, U.A. et al. 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. Support Care Cancer 31, 637 (2023). https://doi.org/10.1007/s00520-023-08082-x

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