TY - JOUR
T1 - Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial
AU - Ruddy, Kathryn J.
AU - Le-Rademacher, Jennifer
AU - Lacouture, Mario E.
AU - Wilkinson, Mary
AU - Onitilo, Adedayo A.
AU - Vander Woude, Amy C.
AU - Grosse-Perdekamp, Maria T.
AU - Dockter, Travis
AU - Tan, Angelina D.
AU - Beutler, Andreas
AU - Loprinzi, Charles L.
N1 - Funding Information:
This work was supported by the Breast Cancer Research Foundation (BCRF) . MEL is funded in part through the NIH / NCI Cancer Center Support Grant P30 CA008748 .
Funding Information:
This work was supported by the Breast Cancer Research Foundation (BCRF). MEL is funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748.
Funding Information:
CLL reports grant funding from Breast Cancer Research Foundation during the conduct of this study and a consultant/advisory role with PledPharma, Metys, Disarm Therapeutics, and Asahi – all regarding efforts to reduce chemotherapy-induced neuropathy. MEL reports personal fees and non-financial support, outside the submitted work and Consulting for MERCK SHARP & DOHME CORPORATION, GALDERMA, JANSSEN RESEARCH & DEVELOPMENT, LLC, ABBVIE, INC., HELSINN HEALTHCARE SA, NOVOCURE INC, BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG, F. HOFFMANN-LA ROCHE AG, ALLERGAN INC., AMGEN INC., E.R. SQUIBB & SONS, L.L.C., NOVARTIS PHARMACEUTICALS CORPORATION, EMD SERONO, INC., ASTRAZENECA PHARMACEUTICALS LP, GENENTECH, INC, LEO PHARMA INC, SEATTLE GENETICS, DEBIOPHARM, LINDI, BAYER, MANNER SAS, MENLO THER, CELLDEX, ABBVIE, LUTRIS, PIERRE FABRE, LEGACY HEALTHCARE, ROCHE, AMRYT PHARMA, JOHNSON & JOHNSON, PAXMAN COOLERS, ADJUCARE, DIGNITANA, BIOTECHSPERT, PAREXEL, and ADGERO. All other authors declare that they have no conflict of interest.
Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/12
Y1 - 2019/12
N2 - Purpose: This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy. Methods: This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials. Results: Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01). Conclusion: While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.
AB - Purpose: This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy. Methods: This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials. Results: Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01). Conclusion: While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.
KW - Chemotherapy-induced neuropathy
KW - Cryotherapy
KW - Paclitaxel acute pain syndrome
KW - Paclitaxel-associated neuropathy
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U2 - 10.1016/j.breast.2019.09.011
DO - 10.1016/j.breast.2019.09.011
M3 - Article
C2 - 31590108
AN - SCOPUS:85072808471
VL - 48
SP - 89
EP - 97
JO - Breast
JF - Breast
SN - 0960-9776
ER -