Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 89-97 |
| Number of pages | 9 |
| Journal | Breast |
| Volume | 48 |
| DOIs | |
| State | Published - Dec 2019 |
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Keywords
- Chemotherapy-induced neuropathy
- Cryotherapy
- Paclitaxel acute pain syndrome
- Paclitaxel-associated neuropathy
ASJC Scopus subject areas
- Surgery
Cite this
Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial. / Ruddy, Kathryn J.; Le-Rademacher, Jennifer; Lacouture, Mario E.; Wilkinson, Mary; Onitilo, Adedayo A.; Vander Woude, Amy C.; Grosse-Perdekamp, Maria T.; Dockter, Travis; Tan, Angelina D.; Beutler, Andreas; Loprinzi, Charles L.
In: Breast, Vol. 48, 12.2019, p. 89-97.Research output: Contribution to journal › Article
}
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.
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
UR - http://www.scopus.com/inward/record.url?scp=85072808471&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072808471&partnerID=8YFLogxK
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 -