Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial
Akiko Hanai, Hiroshi Ishiguro, Takashi Sozu, Moe Tsuda, Ikuko Yano, Takayuki Nakagawa, Satoshi Imai, Yoko Hamabe, Masakazu Toi, Hidenori Arai, Tadao Tsuboyama, Akiko Hanai, Hiroshi Ishiguro, Takashi Sozu, Moe Tsuda, Ikuko Yano, Takayuki Nakagawa, Satoshi Imai, Yoko Hamabe, Masakazu Toi, Hidenori Arai, Tadao Tsuboyama
Abstract
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting and disabling side effect of taxane anticancer agents. We prospectively evaluated the efficacy of cryotherapy for CIPN prevention.
Methods: Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for one hour) wore frozen gloves and socks on the dominant side for 90 minutes, including the entire duration of drug infusion. Symptoms on the treated sides were compared with those on the untreated (nondominant) sides. The primary end point was CIPN incidence assessed by changes in tactile sensitivity from pretreatment baseline in a monofilament test at a cumulative dose of 960 mg/m2. We also assessed thermosensory deficits, subjective symptoms (Patient Neuropathy Questionnaire [PNQ]), manipulative dexterity, and the time to events and hazard ratio by PNQ. All statistical tests were two-sided.
Results: Among the 40 patients, four did not reach the cumulative dose (due to the occurrence of pneumonia, severe fatigue, severe liver dysfunction, and macular edema), leaving 36 patients for analysis. None dropped out due to cold intolerance. The incidence of objective and subjective CIPN signs was clinically and statistically significantly lower on the intervention side than on the control (hand: tactile sensitivity = 27.8% vs 80.6%, odds ratio [OR] = 20.00, 95% confidence interval [CI] = 3.20 to 828.96, P < .001; foot: tacile sensitivity = 25.0% vs 63.9%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; hand: warm sense = 8.8% vs 32.4%, OR = 9.00, 95% CI = 1.25 to 394.48, P = .02; foot: warm sense: 33.4% vs 57.6%, OR = 5.00, 95% CI = 1.07 to 46.93, P = .04; hand: PNQ = 2.8% vs 41.7%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; foot: PNQ = 2.8% vs 36.1%, OR = infinite, 95% CI = 2.78 to infinite, P < .001; hand: hazard ratio [HR] = 0.13, 95% CI = 0.05 to 0.34; foot: HR = 0.13, 95% CI = 0.04 to 0.38, dexterity mean delay = -2.5 seconds, SD = 12.0 seconds, vs + 8.6 seconds, SD = 25.8 seconds, P = .005).
Conclusions: Cryotherapy is useful for preventing both the objective and subjective symptoms of CIPN and resultant dysfunction.
Figures
References
- Cavaletti G, Marmiroli P.. Chemotherapy-induced peripheral neurotoxicity. Nat Rev Neurol. 2010;6(12):657–666.
- Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L.. Chemotherapy-induced peripheral neuropathy and its association with quality of life: A systematic review. Support Care Cancer. 2014;22(8):2261–2269.
- Speck RM, Sammel MD, Farrar JT, et al. . Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. J Oncol Pract. 2013;9(5):e234–e240.
- Hershman DL, Lacchetti C, Dworkin RH, et al. . 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):1941–1967.
- Smith EML, Pang H, Cirrincione C, et al. . Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: A randomized clinical trial. JAMA. 2013;309(13):1359–1367.
- Kadakia KC, Rozell SA, Butala AA, Loprinzi CL.. Supportive cryotherapy: A review from head to toe. J Pain Symptom Manage. 2014;47(6):1100–1115.
- 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(7):1625–1631.
- Scotté F, Tourani J-M, 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(19):4424–4429.
- Eckhoff L, Knoop AS, Jensen M-B, 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;142(1):109–118.
- Alberti P, Rossi E, Cornblath DR, et al. . Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: Two sides of the same coin. Ann Oncol. 2014;25(1):257–264.
- Shimozuma K, Ohashi Y, Takeuchi A, et al. . Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009;17(12):1483–1491.
- Sparano JA, Wang M, Martino S, et al. . Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008;358(16):1663–1671.
- Jayaprakash P, Bhansali A, Bhansali S, et al. . Validation of bedside methods in evaluation of diabetic peripheral neuropathy. Indian J Med Res. 2011;133(6):645–649.
- Dougherty PM, Cata JP, Cordella J V, Burton A, Weng H-R.. Taxol-induced sensory disturbance is characterized by preferential impairment of myelinated fiber function in cancer patients. Pain. 2004;109(1–2):132–142.
- Bryden PJ, Roy EA.. A new method of administering the Grooved Pegboard Test: Performance as a function of handedness and sex. Brain Cogn. 2005;58(3):258–268.
- Kimura J. Electrodiagnosis in Diseases of Nerve and Muscle: Principles and Practice. 4th ed.Oxford: Oxford University Press; 2013.
- Neuval Database II–Normative Data. Neurometer CPT Sensory Nerve Conduction Threshold Current Perception Threshold Test (sNCT/CPT). 2004. . Accessed September 10, 2016.
- Onoue H, Yano I, Tanaka A, et al. . Significant effect of age on docetaxel pharmacokinetics in Japanese female breast cancer patients by using the population modeling approach. Eur J Clin Pharmacol. 2016;72(6):703–710.
- Huizenga C, Zhang H, Arens E, Wang D.. Skin and core temperature response to partial- and whole-body heating and cooling. J Therm Biol. 2004;29(7):549–558.
- Zhang J, Tuckett RP.. Comparison of paclitaxel and cisplatin effects on the slowly adapting type I mechanoreceptor. Brain Res. 2008;1214:50–57.
- Park SB, Goldstein D, Krishnan A V, et al. . Chemotherapy-induced peripheral neurotoxicity: A critical analysis. CA Cancer J Clin. 2013;63(6):419–437.
- Tsuyuki S, Senda N, Kanng Y, et al. . 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.
- Bennett GJ, Liu GK, Xiao WH, Jin HW, Siau C.. Terminal arbor degeneration—a novel lesion produced by the antineoplastic agent paclitaxel. Eur J Neurosci. 2011;33(9):1667–1676.
- Mielke S, Sparreboom A, Steinberg SM, et al. . Association of paclitaxel pharmacokinetics with the development of peripheral neuropathy in patients with advanced cancer. Clin Cancer Res. 2005;11(13):4843–4850.
Source: PubMed