Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial
Introduction: We conducted a randomized controlled trial evaluating the efficacy and tolerability of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early breast cancer receiving neo/adjuvant weekly paclitaxel.Methods: Patients were recruited from the Nat...
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Frontiers Media S.A.
2020-12-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2020.604688/full |
| _version_ | 1819320266996580352 |
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| author | Ding Quan Ng Ding Quan Ng Chia Jie Tan Boon Chua Soh Mabel May Leng Tan Soon Yue Loh Yam Eng Tan Hui Hui Ong Peggy Pei Chee Teng Jack Junjie Chan Wen Yee Chay Joycelyn Lee Gillianne Lai Sok Yuen Beh Tira Jing Ying Tan Yoon Sim Yap Guek Eng Lee Mabel Wong Rebecca Dent Rebecca Dent Yew Long Lo Yew Long Lo Yew Long Lo Alexandre Chan Alexandre Chan Alexandre Chan Kiley Wei-Jen Loh Kiley Wei-Jen Loh |
| author_facet | Ding Quan Ng Ding Quan Ng Chia Jie Tan Boon Chua Soh Mabel May Leng Tan Soon Yue Loh Yam Eng Tan Hui Hui Ong Peggy Pei Chee Teng Jack Junjie Chan Wen Yee Chay Joycelyn Lee Gillianne Lai Sok Yuen Beh Tira Jing Ying Tan Yoon Sim Yap Guek Eng Lee Mabel Wong Rebecca Dent Rebecca Dent Yew Long Lo Yew Long Lo Yew Long Lo Alexandre Chan Alexandre Chan Alexandre Chan Kiley Wei-Jen Loh Kiley Wei-Jen Loh |
| author_sort | Ding Quan Ng |
| collection | DOAJ |
| description | Introduction: We conducted a randomized controlled trial evaluating the efficacy and tolerability of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early breast cancer receiving neo/adjuvant weekly paclitaxel.Methods: Patients were recruited from the National Cancer Centre Singapore and randomized (1:1) to receive either cryotherapy or usual care. Cryotherapy was applied as frozen gloves and socks on all extremities from 15 min before paclitaxel until 15 min post-infusion every cycle. Efficacy was measured by patient-reported outcomes (Patient Neurotoxicity Questionnaire [PNQ] and EORTC QLQ-CIPN20) and electrophysiological assessments. The primary endpoint was PNQ severity at 2 weeks after 12 cycles of weekly paclitaxel.Results: A total of 46 patients were recruited, of which 8 dropped out before paclitaxel treatment, leaving 38 evaluable. There was no significant difference in PNQ severity between cryotherapy and usual care at 2 weeks after paclitaxel treatment (sensory: p = 0.721; motor: p = 1.000). A benefit was observed at 3 months post-paclitaxel based on PNQ (sensory: 14.3 vs. 41.2%, p = 0.078; motor: 0 vs. 29.4%, p = 0.012) and CIPN20 (sensory: β = −3.6, 95%CI = −10.5–3.4, p = 0.308; motor: β = −7.3, 95%CI = −14.6–0, p = 0.051). Additionally, cryotherapy subjects have lower CIPN20 autonomic score (β = −5.84, 95%CI = −11.15 to −0.524, p = 0.031) and higher sympathetic skin response hand amplitudes (β = 0.544, 95%CI = 0.108–0.98, p = 0.014), suggesting possible autonomic benefits from cryotherapy. Temporary interruption with cryotherapy occurred in 80.9% of the subjects due to cold intolerance.Conclusions: There is insufficient evidence that cryotherapy prevents sensory neuropathy which may be due to the high rates of cryotherapy interruption in this study. The autonomic benefits of cryotherapy should be further investigated with appropriate outcome measures.Clinical Trial Registration:ClinicalTrials.gov: NCT03429972. |
| first_indexed | 2024-12-24T11:16:51Z |
| format | Article |
| id | doaj.art-9aef21838ec24261b1d2bd93db794850 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-12-24T11:16:51Z |
| publishDate | 2020-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-9aef21838ec24261b1d2bd93db7948502022-12-21T16:58:21ZengFrontiers Media S.A.Frontiers in Neurology1664-22952020-12-011110.3389/fneur.2020.604688604688Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled TrialDing Quan Ng0Ding Quan Ng1Chia Jie Tan2Boon Chua Soh3Mabel May Leng Tan4Soon Yue Loh5Yam Eng Tan6Hui Hui Ong7Peggy Pei Chee Teng8Jack Junjie Chan9Wen Yee Chay10Joycelyn Lee11Gillianne Lai12Sok Yuen Beh13Tira Jing Ying Tan14Yoon Sim Yap15Guek Eng Lee16Mabel Wong17Rebecca Dent18Rebecca Dent19Yew Long Lo20Yew Long Lo21Yew Long Lo22Alexandre Chan23Alexandre Chan24Alexandre Chan25Kiley Wei-Jen Loh26Kiley Wei-Jen Loh27Department of Pharmacy, National University of Singapore, Singapore, SingaporeDepartment of Clinical Pharmacy Practice, University of California, Irvine, Irvine, CA, United StatesDepartment of Pharmacy, National University of Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Nursing, National Cancer Centre Singapore, Singapore, SingaporeDivision of Nursing, National Cancer Centre Singapore, Singapore, SingaporeDepartment of Neurology, Singapore General Hospital, Singapore, SingaporeDepartment of Neurology, Singapore General Hospital, Singapore, SingaporeDepartment of Neurology, Singapore General Hospital, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDuke-NUS Medical School, Singapore, SingaporeDepartment of Neurology, Singapore General Hospital, Singapore, SingaporeDuke-NUS Medical School, Singapore, SingaporeNational Neuroscience Institute, Singapore, SingaporeDepartment of Clinical Pharmacy Practice, University of California, Irvine, Irvine, CA, United StatesDuke-NUS Medical School, Singapore, SingaporeDepartment of Pharmacy, National Cancer Centre Singapore, Singapore, SingaporeDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, SingaporeDuke-NUS Medical School, Singapore, SingaporeIntroduction: We conducted a randomized controlled trial evaluating the efficacy and tolerability of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early breast cancer receiving neo/adjuvant weekly paclitaxel.Methods: Patients were recruited from the National Cancer Centre Singapore and randomized (1:1) to receive either cryotherapy or usual care. Cryotherapy was applied as frozen gloves and socks on all extremities from 15 min before paclitaxel until 15 min post-infusion every cycle. Efficacy was measured by patient-reported outcomes (Patient Neurotoxicity Questionnaire [PNQ] and EORTC QLQ-CIPN20) and electrophysiological assessments. The primary endpoint was PNQ severity at 2 weeks after 12 cycles of weekly paclitaxel.Results: A total of 46 patients were recruited, of which 8 dropped out before paclitaxel treatment, leaving 38 evaluable. There was no significant difference in PNQ severity between cryotherapy and usual care at 2 weeks after paclitaxel treatment (sensory: p = 0.721; motor: p = 1.000). A benefit was observed at 3 months post-paclitaxel based on PNQ (sensory: 14.3 vs. 41.2%, p = 0.078; motor: 0 vs. 29.4%, p = 0.012) and CIPN20 (sensory: β = −3.6, 95%CI = −10.5–3.4, p = 0.308; motor: β = −7.3, 95%CI = −14.6–0, p = 0.051). Additionally, cryotherapy subjects have lower CIPN20 autonomic score (β = −5.84, 95%CI = −11.15 to −0.524, p = 0.031) and higher sympathetic skin response hand amplitudes (β = 0.544, 95%CI = 0.108–0.98, p = 0.014), suggesting possible autonomic benefits from cryotherapy. Temporary interruption with cryotherapy occurred in 80.9% of the subjects due to cold intolerance.Conclusions: There is insufficient evidence that cryotherapy prevents sensory neuropathy which may be due to the high rates of cryotherapy interruption in this study. The autonomic benefits of cryotherapy should be further investigated with appropriate outcome measures.Clinical Trial Registration:ClinicalTrials.gov: NCT03429972.https://www.frontiersin.org/articles/10.3389/fneur.2020.604688/fullbreast cancerpaclitaxelchemotherapy-induced peripheral neuropathycryotherapypatient-reported outcomeelectrophysiological assessment |
| spellingShingle | Ding Quan Ng Ding Quan Ng Chia Jie Tan Boon Chua Soh Mabel May Leng Tan Soon Yue Loh Yam Eng Tan Hui Hui Ong Peggy Pei Chee Teng Jack Junjie Chan Wen Yee Chay Joycelyn Lee Gillianne Lai Sok Yuen Beh Tira Jing Ying Tan Yoon Sim Yap Guek Eng Lee Mabel Wong Rebecca Dent Rebecca Dent Yew Long Lo Yew Long Lo Yew Long Lo Alexandre Chan Alexandre Chan Alexandre Chan Kiley Wei-Jen Loh Kiley Wei-Jen Loh Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial Frontiers in Neurology breast cancer paclitaxel chemotherapy-induced peripheral neuropathy cryotherapy patient-reported outcome electrophysiological assessment |
| title | Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial |
| title_full | Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial |
| title_fullStr | Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial |
| title_full_unstemmed | Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial |
| title_short | Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial |
| title_sort | impact of cryotherapy on sensory motor and autonomic neuropathy in breast cancer patients receiving paclitaxel a randomized controlled trial |
| topic | breast cancer paclitaxel chemotherapy-induced peripheral neuropathy cryotherapy patient-reported outcome electrophysiological assessment |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2020.604688/full |
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