TY - JOUR
T1 - A pilot randomized, placebo-controlled, double-blind study of omega-3 fatty acids to prevent paclitaxel-associated acute pain syndrome in breast cancer patients
T2 - Alliance A22_Pilot2
AU - Tawfik, Bernard
AU - Dayao, Zoneddy R.
AU - Brown-Glaberman, Ursa Abigail
AU - Pankratz, V. Shane
AU - Lafky, Jacqueline M.
AU - Loprinzi, Charles L.
AU - Barton, Debra L.
N1 - Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Breast cancer
KW - Chronic chemotherapy-induced peripheral neuropathy (CIPN)
KW - Omega-3 fatty acids
KW - Paclitaxel
KW - Paclitaxel acute pain syndrome
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U2 - 10.1007/s00520-023-08082-x
DO - 10.1007/s00520-023-08082-x
M3 - Article
C2 - 37847317
AN - SCOPUS:85174230556
SN - 0941-4355
VL - 31
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 12
M1 - 637
ER -