Cropsi Study: Efficacy and Safety of Cryotherapy and Cryocompression in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients with Breast and Gynecological Cancer-A Prospective, Randomized Trial

Overview

Journal Breast

Publisher Elsevier

Specialties Endocrinology
Oncology

Date 2024 Jun 28

PMID 38941655

Authors

Christine Brunner

Miriam Emmelheinz

Daniel Egle

Magdalena Ritter

Katharina Leitner

Verena Wieser

Carmen Albertini

Samira Abdel Azim

Irene Mutz-Dehbalaie

Johanna Kogl

Christian Marth

Affiliations

Soon will be listed here.

Abstract

Objective: This study aimed to demonstrate the superiority of cryocompression over cryotherapy alone in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) grade 2 or above.

Methods: This prospective randomized study was conducted between May 2020 and January 2023 in Innsbruck. Eligible patients had a diagnosis of gynecological cancer and received a minimum of 3 cycles of taxane-based CT (neoadjuvant, adjuvant or palliative therapy). Patients were randomized 1:1 to receive either cryotherapy or cryocompression on their upper extremities during chemotherapy (CT). We performed temperature measurements, two QoL questionnaires and neurological tests during CT and at follow-up 3 and 6-9 months after the completion of CT. CIPN was assessed using the CTCAE score.

Results: Of 200 patients recruited, both groups showed a lower prevalence of CIPN in this study compared to recent literature. In the group receiving cryotherapy, the prevalence of grade 1 CIPN was 30.1 %, and that of grade 2 CIPN or above was 13.7 %; in the group treated with cryocompression, the prevalence of grade 1 CIPN was 32.8 %, and that of grade 2 or above CIPN was 17.2 %. We found a significant reduction in temperature in the cryotherapy and cryocompression groups. Regarding the two QOL questionnaires as well as the neurological tests no significant differences were found between the two groups.

Conclusion: Our study suggests that cryotherapy as well as cryocompression is a safe and effective way to cool patients' extremities to lower the prevalence of CIPN. Cryocompression was not more effective than cryotherapy alone in the prevention of CIPN.

References

Oneda E, Meriggi F, Zanotti L, Zaina E, Bighe S, Andreis F . Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience. Integr Cancer Ther. 2020; 19:1534735420943287. PMC: 7457652. DOI: 10.1177/1534735420943287. View

Sung H, Ferlay J, Siegel R, Laversanne M, Soerjomataram I, Jemal A . Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021; 71(3):209-249. DOI: 10.3322/caac.21660. View

Chitkumarn P, Rahong T, Achariyapota V . Efficacy of Siriraj, in-house-developed, frozen gloves for cold therapy reduction of chemotherapy-induced peripheral neuropathy in gynecological cancer patients: randomized controlled trial. Support Care Cancer. 2022; 30(6):4835-4843. PMC: 9046355. DOI: 10.1007/s00520-022-06890-1. View

Korde L, Somerfield M, Carey L, Crews J, Denduluri N, Hwang E . Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline. J Clin Oncol. 2021; 39(13):1485-1505. PMC: 8274745. DOI: 10.1200/JCO.20.03399. View

Oneda E, Abeni C, Zanotti L, Zaina E, Bighe S, Zaniboni A . Chemotherapy-induced neurotoxicity in the treatment of gynecological cancers: State of art and an innovative approach for prevention. World J Clin Oncol. 2021; 12(6):458-467. PMC: 8223716. DOI: 10.5306/wjco.v12.i6.458. View

Burgess J, Ferdousi M, Gosal D, Boon C, Matsumoto K, Marshall A . Chemotherapy-Induced Peripheral Neuropathy: Epidemiology, Pathomechanisms and Treatment. Oncol Ther. 2021; 9(2):385-450. PMC: 8593126. DOI: 10.1007/s40487-021-00168-y. View

Hong J, Tian J, Wu L . The influence of chemotherapy-induced neurotoxicity on psychological distress and sleep disturbance in cancer patients. Curr Oncol. 2014; 21(4):174-80. PMC: 4117615. DOI: 10.3747/co.21.1984. View

Jia J, Guo Y, Sundar R, Bandla A, Hao Z . Cryotherapy for Prevention of Taxane-Induced Peripheral Neuropathy: A Meta-Analysis. Front Oncol. 2021; 11:781812. PMC: 8667340. DOI: 10.3389/fonc.2021.781812. View

Jordan B, Jahn F, Sauer S, Jordan K . Prevention and Management of Chemotherapy-Induced Polyneuropathy. Breast Care (Basel). 2019; 14(2):79-84. PMC: 6886110. DOI: 10.1159/000499599. View

10.

Shigematsu H, Hirata T, Nishina M, Yasui D, Ozaki S . Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients. Support Care Cancer. 2020; 28(10):5005-5011. PMC: 7447649. DOI: 10.1007/s00520-020-05345-9. View

11.

Glare P, Davies P, Finlay E, Gulati A, Lemanne D, Moryl N . Pain in cancer survivors. J Clin Oncol. 2014; 32(16):1739-47. PMC: 4031191. DOI: 10.1200/JCO.2013.52.4629. View

12.

Bandla A, Tan S, Kumarakulasinghe N, Huang Y, Ang S, Magarajah G . Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Support Care Cancer. 2019; 28(8):3691-3699. PMC: 7316694. DOI: 10.1007/s00520-019-05177-2. View

13.

Tsuyuki S, Senda N, Kanng Y, Yamaguchi A, Yoshibayashi H, Kikawa Y . Evaluation of the effect of compression therapy using surgical gloves on nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: a phase II multicenter study by the Kamigata Breast Cancer Study Group. Breast Cancer Res Treat. 2016; 160(1):61-67. DOI: 10.1007/s10549-016-3977-7. View

14.

Griffith K, Dorsey S, Renn C, Zhu S, Johantgen M, Cornblath D . Correspondence between neurophysiological and clinical measurements of chemotherapy-induced peripheral neuropathy: secondary analysis of data from the CI-PeriNomS study. J Peripher Nerv Syst. 2014; 19(2):127-35. PMC: 4175057. DOI: 10.1111/jns5.12064. View

15.

Kotani H, Terada M, Mori M, Horisawa N, Sugino K, Kataoka A . Compression therapy using surgical gloves does not prevent paclitaxel-induced peripheral neuropathy: results from a double-blind phase 2 trial. BMC Cancer. 2021; 21(1):548. PMC: 8120772. DOI: 10.1186/s12885-021-08240-6. View

16.

Vanderpuye V, Clemenceau J, Temin S, Aziz Z, Burke W, Cevallos N . Assessment of Adult Women With Ovarian Masses and Treatment of Epithelial Ovarian Cancer: ASCO Resource-Stratified Guideline. JCO Glob Oncol. 2021; 7:1032-1066. PMC: 8457806. DOI: 10.1200/GO.21.00085. View

17.

Mazzeo A, Pace A, Pessino A, Schenone A, Toscano A, Argyriou A . The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings. Ann Oncol. 2012; 24(2):454-462. PMC: 3551481. DOI: 10.1093/annonc/mds329. View

18.

Ibrahim E, Ehrlich B . Prevention of chemotherapy-induced peripheral neuropathy: A review of recent findings. Crit Rev Oncol Hematol. 2019; 145:102831. PMC: 6982645. DOI: 10.1016/j.critrevonc.2019.102831. View

19.

Hershman D, Lacchetti C, Dworkin R, Smith E, Bleeker J, Cavaletti G . 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; 32(18):1941-67. DOI: 10.1200/JCO.2013.54.0914. View

20.

Stubblefield M, Burstein H, Burton A, Custodio C, Deng G, Ho M . NCCN task force report: management of neuropathy in cancer. J Natl Compr Canc Netw. 2009; 7 Suppl 5:S1-S26. DOI: 10.6004/jnccn.2009.0078. View