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Original Study|Articles in Press

Mild cryotherapy for prevention of paclitaxel-induced nail toxicity in breast cancer patients: A phase II single-arm clinical trial

Published:March 07, 2023DOI:https://doi.org/10.1016/j.clbc.2023.03.004

      Abstract

      Background

      Nail changes are among the most common dermatological adverse events in paclitaxel-receiving patients. Although effective, low-temperature prophylactic cryotherapy is discomforting and a potential cause of side effects, resulting in low patients’ adherence.

      Patients and Methods

      A phase 2 single-arm study evaluating mild cryotherapy for the reduction of 12-week, grade 2 nail toxicity was conducted on 67 taxane-naïve breast cancer patients (age 18-74 years) undergoing weekly adjuvant chemotherapy with paclitaxel. Instant-ice packs were fixed over the fingers and toes for a total of 70 minutes during paclitaxel infusion at a temperature between -5°C and +5°C. Nail toxicity was evaluated weekly (CTCAE v. 4.03), including grade 2 (i.e., onycholysis, subungual hematoma, onychomadesis) and grade 1 nail toxicities.

      Results

      Twelve patients experienced grade 2 nail toxicities (17.9%, 95% confidence interval [CI] 9.6-29.2%; median time to onset: 56 days): onycholysis was the most frequent grade 2 toxicity (13.4%), followed by subungual hematoma (9.0%) and onychomadesis (1.5%). Grade 1 toxicity occurred in 33 patients (63.5%, 95% CI 49.0-76.4%) with nail discoloration representing by far the most frequent toxicity (59.6%). Seventeen patients (25.4%) reported no nail toxicity. 62.7% of patients reported no pain and 22.4% suffered moderate pain. No patient experienced severe pain or others adverse effects.

      Conclusions

      Instant-ice pack is a feasible prophylactic intervention for nail toxicity, well tolerated by patients and with limited impact on routine workload. It could be considered for patients refusing (or interrupting) cryotherapy, and it can be implemented when frozen gloves management is not feasible.

      MicroAbstract

      A phase 2, single-arm trial was conducted to evaluate mild-temperature cryotherapy efficacy in preventing paclitaxel-induced nail toxicity. Instant-ice packs were fixed over the fingers and toes of 67 breast cancer patients for 70 minutes during paclitaxel infusion. Twelve patients (18%) reported grade 2 nail toxicity. This is a well-tolerated prophylactic treatment that can be proposed to patients refusing low-temperature cryotherapy.

      Keywords

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      References

        • Crown J
        • O'Leary M
        • Ooi WS
        Docetaxel and paclitaxel in the treatment of breast cancer: a review of clinical experience.
        Oncologist. 2004; 9 (Suppl): 24-32https://doi.org/10.1634/theoncologist.9-suppl_2-24
        • Markman M.
        Managing taxane toxicities.
        Support Care Cancer. 2003; 11: 144-147https://doi.org/10.1007/s00520-002-0405-9
        • Sibaud V
        • Lebœuf NR
        • Roche H
        • et al.
        Dermatological adverse events with taxane chemotherapy.
        Eur J Dermatol. 2016; 26: 427-443https://doi.org/10.1684/ejd.2016.2833
        • Minisini AM
        • Tosti A
        • Sobrero AF
        • et al.
        Taxane-induced nail changes: incidence, clinical presentation and outcome.
        Ann Oncol. 2003; 14: 333-337https://doi.org/10.1093/annonc/mdg050
        • Capriotti K
        • Capriotti JA
        • Lessin S
        • et al.
        The risk of nail changes with taxane chemotherapy: a systematic review of the literature and meta-analysis.
        Br J Dermatol. 2015; 173: 842-845https://doi.org/10.1111/bjd.13743
        • McCarthy AL
        • Shaban RZ
        • Gillespie K
        • Vick J.
        Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial.
        Support Care Cancer. 2014; 22: 1375-1383https://doi.org/10.1007/s00520-013-2095-x
        • Marks DH
        • Qureshi A
        • Friedman A.
        Evaluation of Prevention Interventions for Taxane-Induced Dermatologic Adverse Events: A Systematic Review.
        JAMA Dermatol. 2018; 154: 1465-1472https://doi.org/10.1001/jamadermatol.2018.3465
        • Huang KL
        • Lin KY
        • Huang TW
        • et al.
        Prophylactic management for taxane-induced nail toxicity: A systematic review and meta-analysis.
        Eur J Cancer Care (Engl). 2019; 28: e13118https://doi.org/10.1111/ecc.13118
        • Coolbrandt A
        • Vancoille K
        • Dejaeger E
        • et al.
        Preventing taxane-related peripheral neuropathy, pain and nail toxicity: a prospective self-controlled trial comparing hilotherapy with frozen gloves in early breast cancer.
        Breast Cancer Res Treat. 2022; (Published online January 4)https://doi.org/10.1007/s10549-021-06477-0
        • 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; 16: 270-275https://doi.org/10.1016/j.ejon.2011.06.007
        • Ishiguro H
        • Takashima S
        • Yoshimura K
        • et al.
        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; 20: 2017-2024https://doi.org/10.1007/s00520-011-1308-4
        • Scotté F
        • Tourani JM
        • Banu E
        • et al.
        Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand.
        J Clin Oncol. 2005; 23: 4424-4429https://doi.org/10.1200/JCO.2005.15.651
        • 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: 5005-5011https://doi.org/10.1007/s00520-020-05345-9
        • Begon E
        • Blum L
        • Fraboulet G
        • Assouad S
        • Bachmeyer C.
        Frostbite as a complication of frozen gloves in the prevention of docetaxel-induced onycholysis.
        Eur J Dermatol. 2011; 21: 628-629https://doi.org/10.1684/ejd.2011.1390
        • Matsumoto K
        • Hino C
        • Fukuda K
        • et al.
        Prospective Study of Ice Gel Pack as Less Expensive Alternative for Prevention of Skin and Nail Toxicity in Patients with Breast Cancer Receiving Docetaxel.
        Poster Session Abstracts. 2009; (1114): 1114https://doi.org/10.1158/0008-5472.SABCS-09-1114
        • Kim JY
        • Ok ON
        • Seo JJ
        • et al.
        A prospective randomized controlled trial of hydrating nail solution for prevention or treatment of onycholysis in breast cancer patients who received neoadjuvant/adjuvant docetaxel chemotherapy.
        Breast Cancer Res Treat. 2017; 164: 617-625https://doi.org/10.1007/s10549-017-4268-7
        • Williamson A
        • Hoggart B.
        Pain: a review of three commonly used pain rating scales.
        J Clin Nurs. 2005; 14: 798-804https://doi.org/10.1111/j.1365-2702.2005.01121.x
        • A'Hern RP.
        Sample size tables for exact single-stage phase II designs.
        Stat Med. 2001; 20: 859-866https://doi.org/10.1002/sim.721
        • Scotté F
        • Banu E
        • Medioni J
        • et al.
        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; 112: 1625-1631https://doi.org/10.1002/cncr.23333
        • 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; 5: 276-282https://doi.org/10.1159/000497824