Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial
| Autor: | Jennifer Le-Rademacher, Mary Wilkinson, Maria T. Grosse-Perdekamp, Charles L. Loprinzi, Kathryn J. Ruddy, Andreas S. Beutler, Mario E. Lacouture, Travis J. Dockter, Angelina D. Tan, Amy C. Vander Woude, Adedayo A. Onitilo |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Paclitaxel medicine.medical_treatment Cryotherapy Breast Neoplasms Pilot Projects Placebo Article law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Standard care law medicine Humans In patient 030212 general & internal medicine Prospective Studies Aged business.industry Foot Area under the curve Peripheral Nervous System Diseases General Medicine Middle Aged medicine.disease Hand Antineoplastic Agents Phytogenic Surgery Peripheral neuropathy chemistry 030220 oncology & carcinogenesis Female business |
| Zdroj: | Breast |
| ISSN: | 1532-3080 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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