Clinical trial NCT04558034 - References

Peripheral Neuropathy — The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer

Citation(s)

•   Alessandrini A, Starace M, Cerè G, Brandi N, Piraccini BM
  Management and Outcome of Taxane-Induced Nail Side Effects: Experience of 79 Patients from a Single Centre. Skin Appendage Disord. 2019 Aug;5(5):276-282. doi: 10.1159/000497824. Epub 2019 Mar 22.
•   Argyriou AA, Kyritsis AP, Makatsoris T, Kalofonos HP
  Chemotherapy-induced peripheral neuropathy in adults: a comprehensive update of the literature. Cancer Manag Res. 2014 Mar 19;6:135-47. doi: 10.2147/CMAR.S44261. eCollection 2014. Review.
•   Autissier E
  Chemotherapy-Induced Peripheral Neuropathy: Association With Increased Risk of Falls and Injuries. Clin J Oncol Nurs. 2019 Aug 1;23(4):405-410. doi: 10.1188/19.CJON.405-410. Review.
•   Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA
  Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2). doi: 10.1093/jnci/djx162.
•   Bhatnagar B, Gilmore S, Goloubeva O, Pelser C, Medeiros M, Chumsri S, Tkaczuk K, Edelman M, Bao T
  Chemotherapy dose reduction due to chemotherapy induced peripheral neuropathy in breast cancer patients receiving chemotherapy in the neoadjuvant or adjuvant settings: a single-center experience. Springerplus. 2014 Jul 16;3:366. doi: 10.1186/2193-1801-3-366. eCollection 2014.
•   Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F
  Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
•   Can G, Aydiner A, Cavdar I
  Taxane-induced nail changes: Predictors and efficacy of the use of frozen gloves and socks in the prevention of nail toxicity. Eur J Oncol Nurs. 2012 Jul;16(3):270-5. doi: 10.1016/j.ejon.2011.06.007. Epub 2011 Jul 23.
•   Capriotti K, Capriotti JA, Lessin S, Wu S, Goldfarb S, Belum VR, Lacouture ME
  The risk of nail changes with taxane chemotherapy: a systematic review of the literature and meta-analysis. Br J Dermatol. 2015 Sep;173(3):842-5. doi: 10.1111/bjd.13743. Epub 2015 Jul 29. Review.
•   Cassidy J, Misset JL
  Oxaliplatin-related side effects: characteristics and management. Semin Oncol. 2002 Oct;29(5 Suppl 15):11-20. Review.
•   Chan YN, Jheng YW, Wang PJ, Chen CY, Lin MW, Wang YJ
  Taxane-Induced Peripheral Neuropathy: Objective and Subjective Comparison Between Paclitaxel and Docetaxel in Patients With Breast Cancer. Clin J Oncol Nurs. 2019 Oct 1;23(5):494-501. doi: 10.1188/19.CJON.494-501.
•   Childress J, Lokich J
  Cutaneous hand and foot toxicity associated with cancer chemotherapy. Am J Clin Oncol. 2003 Oct;26(5):435-6.
•   Cioroiu C, Weimer LH
  Update on Chemotherapy-Induced Peripheral Neuropathy. Curr Neurol Neurosci Rep. 2017 Jun;17(6):47. doi: 10.1007/s11910-017-0757-7. Review.
•   Cleeland CS, Ryan KM
  Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. Review.
•   Cunningham D, Gilchrist NL, Forrest GJ, Soukop M
  Onycholysis associated with cytotoxic drugs. Br Med J (Clin Res Ed). 1985 Mar 2;290(6469):675-6.
•   Daut RL, Cleeland CS
  The prevalence and severity of pain in cancer. Cancer. 1982 Nov 1;50(9):1913-8.
•   De Giorgi U, Rosti G, Monti M, Frassineti GL, Marangolo M
  Onycholysis secondary to multiple paclitaxel 1-hour infusions: possible role for its vehicle (Cremophor EL). Ann Oncol. 2003 Oct;14(10):1588-9.
•   Descoeur J, Pereira V, Pizzoccaro A, Francois A, Ling B, Maffre V, Couette B, Busserolles J, Courteix C, Noel J, Lazdunski M, Eschalier A, Authier N, Bourinet E
  Oxaliplatin-induced cold hypersensitivity is due to remodelling of ion channel expression in nociceptors. EMBO Mol Med. 2011 May;3(5):266-78. doi: 10.1002/emmm.201100134. Epub 2011 Mar 24.
•   Eckhoff L, Knoop AS, Jensen MB, Ejlertsen B, Ewertz M
  Risk of docetaxel-induced peripheral neuropathy among 1,725 Danish patients with early stage breast cancer. Breast Cancer Res Treat. 2013 Nov;142(1):109-18. doi: 10.1007/s10549-013-2728-2. Epub 2013 Oct 17.
•   Elasto-Gel(2019)
  Elasto-Gel.Retrieved on December 1,2019 from https://www.elastogels.com/product/elasto-gel-hot-cold-therapy-mitten/
•   Flory SM, Solimando DA Jr, Webster GF, Dunton CJ, Neufeld JM, Haffey MB
  Onycholysis associated with weekly administration of paclitaxel. Ann Pharmacother. 1999 May;33(5):584-6.
•   Forsyth PA, Balmaceda C, Peterson K, Seidman AD, Brasher P, DeAngelis LM
  Prospective study of paclitaxel-induced peripheral neuropathy with quantitative sensory testing. J Neurooncol. 1997 Oct;35(1):47-53.
•   Gilbar P, Hain A, Peereboom VM
  Nail toxicity induced by cancer chemotherapy. J Oncol Pharm Pract. 2009 Sep;15(3):143-55. doi: 10.1177/1078155208100450. Epub 2009 Jan 26. Review.
•   Griffiths C, Kwon N, Beaumont JL, Paice JA
  Cold therapy to prevent paclitaxel-induced peripheral neuropathy. Support Care Cancer. 2018 Oct;26(10):3461-3469. doi: 10.1007/s00520-018-4199-9. Epub 2018 Apr 21.
•   Grisold W, Cavaletti G, Windebank AJ
  Peripheral neuropathies from chemotherapeutics and targeted agents: diagnosis, treatment, and prevention. Neuro Oncol. 2012 Sep;14 Suppl 4:iv45-54. doi: 10.1093/neuonc/nos203. Review.
•   Hanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T
  Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178.
•   Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F
  Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol. 2006 Feb;33(1):15-49. Review.
•   Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology
  Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14. Review.
•   Hoffman,K
  (2014). Diagnosing and Treating Chemotherapy-Induced Nail Changes. Podiatry Today,27(2). Retrieved on December 16, 2019from https://www.podiatrytoday.com/diagnosing-and-treating-chemotherapy-induced-nail-changes
•   Hussain S, Anderson DN, Salvatti ME, Adamson B, McManus M, Braverman AS
  Onycholysis as a complication of systemic chemotherapy: report of five cases associated with prolonged weekly paclitaxel therapy and review of the literature. Cancer. 2000 May 15;88(10):2367-71. Review.
•   Ishiguro H, Takashima S, Yoshimura K, Yano I, Yamamoto T, Niimi M, Yamashiro H, Ueno T, Takeuchi M, Sugie T, Yanagihara K, Toi M, Fukushima M
  Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients. Support Care Cancer. 2012 Sep;20(9):2017-24. doi: 10.1007/s00520-011-1308-4. Epub 2011 Nov 16.
•   Kadakia KC, Rozell SA, Butala AA, Loprinzi CL
  Supportive cryotherapy: a review from head to toe. J Pain Symptom Manage. 2014 Jun;47(6):1100-15. doi: 10.1016/j.jpainsymman.2013.07.014. Epub 2013 Nov 7. Review.
•   Kerckhove N, Collin A, Condé S, Chaleteix C, Pezet D, Balayssac D
  Long-Term Effects, Pathophysiological Mechanisms, and Risk Factors of Chemotherapy-Induced Peripheral Neuropathies: A Comprehensive Literature Review. Front Pharmacol. 2017 Feb 24;8:86. doi: 10.3389/fphar.2017.00086. eCollection 2017. Review.
•   Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K
  The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
•   Kumar SP
  Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.
•   LaPointe NE, Morfini G, Brady ST, Feinstein SC, Wilson L, Jordan MA
  Effects of eribulin, vincristine, paclitaxel and ixabepilone on fast axonal transport and kinesin-1 driven microtubule gliding: implications for chemotherapy-induced peripheral neuropathy. Neurotoxicology. 2013 Jul;37:231-9. doi: 10.1016/j.neuro.2013.05.008. Epub 2013 May 24.
•   Lau CP, Hui P, Chan TC
  Docetaxel-induced nail toxicity: a case of severe onycholysis and topic review. Chin Med J (Engl). 2011 Aug;124(16):2559-60. Review.
•   Lee JJ, Swain SM
  Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006 Apr 1;24(10):1633-42. Review.
•   McCarthy AL, Shaban RZ, Gillespie K, Vick J
  Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial. Support Care Cancer. 2014 May;22(5):1375-83. doi: 10.1007/s00520-013-2095-x. Epub 2013 Dec 22.
•   Memorial Sloan Kettering Cancer Center (2017) Nail changes during treatment with Taxane-based chemotherapy Retrieved December17,2019 from https://www
  mskcc.org/pdf/cancer-care/patient-education/nail-changes-during-treatment-taxanes
•   Miltenburg NC, Boogerd W
  Chemotherapy-induced neuropathy: A comprehensive survey. Cancer Treat Rev. 2014 Aug;40(7):872-82. doi: 10.1016/j.ctrv.2014.04.004. Epub 2014 Apr 18. Review.
•   Minisini AM, Tosti A, Sobrero AF, Mansutti M, Piraccini BM, Sacco C, Puglisi F
  Taxane-induced nail changes: incidence, clinical presentation and outcome. Ann Oncol. 2003 Feb;14(2):333-7.
•   Monjazeb S, Wilson J
  Epidermal Growth Factor Receptor Inhibitors: Cutaneous Side Effects and Their Management. Skin Therapy Lett. 2017 Sep;22(5):5-7. Review.
•   Nicolopoulos J, Howard A
  Docetaxel-induced nail dystrophy. Australas J Dermatol. 2002 Nov;43(4):293-6. Review.
•   Oncology Nursing Society
  (2017). Cutaneous reactions. Retrieved on December 11, 2019 from https://www.ons.org/pep/skin-reactions
•   Oncology Nursing Society
  (2019). Peripheral neuropathy . Retrieved on December 11, 2019 from https://www.ons.org/pep/peripheral-neuropathy
•   Park SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC
  Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204. Review.
•   Paul LJ, Cohen PR
  Paclitaxel-associated subungual pyogenic granuloma: report in a patient with breast cancer receiving paclitaxel and review of drug-induced pyogenic granulomas adjacent to and beneath the nail. J Drugs Dermatol. 2012 Feb;11(2):262-8. Review.
•   Peyton L, Fischer-Cartlidge E
  Extremity Cooling: A Synthesis of Cryotherapy Interventions to Reduce Peripheral Neuropathy and Nail Changes From Taxane-Based Chemotherapy. Clin J Oncol Nurs. 2019 Oct 1;23(5):522-528. doi: 10.1188/19.CJON.522-528. Review.
•   Poncelet AN
  An algorithm for the evaluation of peripheral neuropathy. Am Fam Physician. 1998 Feb 15;57(4):755-64. Review.
•   Quasthoff S, Hartung HP
  Chemotherapy-induced peripheral neuropathy. J Neurol. 2002 Jan;249(1):9-17. Review.
•   Rapid Aid
  (2020). Cold Gel Slippers. Retrieved on March 2,2020 from http://rapidaid.com/product/hot-cold-gel-slippers/
•   Robert C, Sibaud V, Mateus C, Verschoore M, Charles C, Lanoy E, Baran R
  Nail toxicities induced by systemic anticancer treatments. Lancet Oncol. 2015 Apr;16(4):e181-9. doi: 10.1016/S1470-2045(14)71133-7. Review.
•   Ross M, Fischer-Cartlidge E
  Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia . Clin J Oncol Nurs. 2017 Apr 1;21(2):226-233. doi: 10.1188/17.CJON.226-233.
•   Sanofi (2019)
  Taxotere prescribing information. Retreived on December 11, 2019 from http://products.sanofi.us/taxotere/Taxotere.html
•   Sato J, Mori M, Nihei S, Kumagai M, Takeuchi S, Kashiwaba M, Kudo K
  The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy. J Pharm Health Care Sci. 2016 Nov 15;2:33. eCollection 2016.
•   Scotté F, Banu E, Medioni J, Levy E, Ebenezer C, Marsan S, Banu A, Tourani JM, Andrieu JM, Oudard S
  Matched case-control phase 2 study to evaluate the use of a frozen sock to prevent docetaxel-induced onycholysis and cutaneous toxicity of the foot. Cancer. 2008 Apr 1;112(7):1625-31. doi: 10.1002/cncr.23333.
•   Scotté F, Tourani JM, Banu E, Peyromaure M, Levy E, Marsan S, Magherini E, Fabre-Guillevin E, Andrieu JM, Oudard S
  Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol. 2005 Jul 1;23(19):4424-9.
•   Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M
  Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. Review.
•   Spazzapan S, Crivellari D, Lombardi D, Scuderi C, Magri MD, Veronesi A, Gatti A
  Nail toxicity related to weekly taxanes: an important issue requiring a change in common toxicity criteria grading? J Clin Oncol. 2002 Nov 1;20(21):4404-5; author reply 4405.
•   Starobova, H
  , Vetter, I. (2017). Pathophysiology of chemotherapy-induced peripheral neuropathy. Frontiers in Molecular Neuroscience, 10, 174. doi:10.3389/fnmol.2017.00174 Retrieved June 25, 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450696/
•   Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP
  Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.
•   Swenson KK, Bell EM, Nissen J
  Nail toxicity associated with paclitaxel treatment for ovarian cancer. Oncol Nurs Forum. 2013 Jan;40(1):17-9. doi: 10.1188/13.ONF.17-19.
•   Tofthagen C, Visovsky CM, Hopgood R
  Chemotherapy-induced peripheral neuropathy: an algorithm to guide nursing management. Clin J Oncol Nurs. 2013 Apr;17(2):138-44. doi: 10.1188/13.CJON.138-144.
•   U
  S Department of Health and Human Services (2017). Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Retrieved on December 12, 2019 from https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf.
•   Wickham R
  Chemotherapy-induced peripheral neuropathy: a review and implications for oncology nursing practice. Clin J Oncol Nurs. 2007 Jun;11(3):361-76. Review.
•   Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S
  Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30. Review.
•   Wilkinson,M
  , Cocilovo,C., & Schar,M. (2016) Reduction of paclitaxel neuropathy with cryotherapy.Journal of Clinical Oncology.34(suppl 3S;abst 124) retrieved on December 2,2019 from https://meetinglibrary.asco.org/record/119151/abstract
•   Willis, W
  D (2000). The nervous system. In R.M. Berne & M.N. Levy (Eds.). Principles of physiology (pp. 68-94). St. Louis: Mosby.
•   Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S
  Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.

The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer

Details for clinical trial NCT04558034