Mild Cryotherapy for Prevention of Paclitaxel-Induced Nail Toxicity in Breast Cancer Patients: A Phase II Single-Arm Clinical Trial.

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 II 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 vs 4.03), including grade 2 (ie, 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.

Estudio de la correlación entre la onicodistrofia en los pies y el índice de masa corporal / Study of the correlation between onychodystrophy in the feet and the body mass index (BMI)

Fundamentos: Las alteraciones ungueales también se asocian a la obesidad. El objetivo de este trabajo fueevaluar la relación entre la onicodistrofia y el índice de masa corporal.Métodos: Se trata de un estudio observacional y transversal realizado en el Servicio de Angiología y CirugíaVascular del Hospital de la Santa Creu i Sant Pau de Barcelona, durante el período 2015-2017. La muestraconsta de 83 pacientes con una edad comprendida entre 40 y 84 años afectados de alteración venosa crónica,en una o en ambas extremidades inferiores. El análisis ungueal se realizó a través de iconografía yonicoscopia. El estado ponderal se estimó a partir del Índice de Masa Corporal (IMC) medido en kg/m2.Resultados: Dentro de la muestra de población estudiada, existe un ligero aumento de onicodistrofia cuantomayor es el índice de masa corporal. Sin embargo, este ligero aumento que se aprecia en la muestra no nospermite concluir, a un nivel de significación estadístico elevado, que también se producirá en la poblaciónobjeto de estudio.Conclusiones: Existe un ligero aumento de onicodistrofia cuanto mayor es el índice de masa corporal. (AU)

Background: Nail alterations are also associated with obesity. The objective was to evaluate the relationshipbetween onychodystrophy and the body mass index.Methods: This is an observational and transversal study conducted in the Angiology and Vascular SurgeryDepartment of the Hospital of the Santa Creu and Sant Pau of Barcelona, during the period 2015-2017. Thesample consists of 83 patients with an age between 40 and 84 years affected by chronic venous alteration, inone or both lower extremities. The nail analysis was performed through iconography and onicoscopy. Takinginto account the mass and height of the patients, their BMI was established.Results: In the population sample studied, there is a slight increase in onychodystrophy as the body massindex increases. However, this slight increase observed in the sample does not allow us to conclude, at a highlevel of statistical significance, that it will also occur in the population under study.Conclusions: There is a slight increase in onychodystrophy when the body mass index increases. (AU)

A Timeline of Onychomycosis Therapy and Future Directions.

Onychomycosis was first described in the mid-1800's, and early treatment regimens involved applying corrosive substances and nail plate avulsion. It was not until the mid-1900's that more specific antifungal agents were utilized. Initially, only oral drugs were used, with ciclopirox 8% solution later approved in 1999. Presently, terbinafine, itraconazole, and fluconazole (off-label) are used for systemic onychomycosis therapy in the US, and topicals include ciclopirox, efinaconazole and tavaborole. Devices, topicals with new mechanisms of action, and oral medications with potentially better efficacy are now being explored for treatment of onychomycosis.

Prophylactic management for taxane-induced nail toxicity: A systematic review and meta-analysis.

OBJECTIVE: This meta-analysis was performed to assess the efficacy of cryotherapy and nail solution (NS) use in preventing nail toxicity (NT) induced by taxane-based chemotherapy. METHODS: PubMed, EMBASE, Cochrane Library and ClinicalTrials.gov registry databases were searched for relevant studies published up to December 2018. The primary outcome was taxane-induced NT. Secondary outcomes were skin toxicity (ST), time to toxicity and patient comfort. RESULTS: We reviewed three randomised control trials and six prospective studies with 708 patients. For meta-analysis, taxane-induced NT grading was compared. NT and ST were significantly lower in the cryotherapy patients than in the controls (grade 1 NT: risk ratio [RR] = 0.51, 95% confidence interval [CI] = 0.30-0.89; grade 2-3 NT: RR = 0.36, 95% CI = 0.11-1.12; total NT: RR = 0.49; 95% CI = 0.30-0.79; ST: RR = 0.46, 95% CI = 0.33-0.64). The NS-treated patients exhibited significantly lower NT than the controls. CONCLUSIONS: Nail solution-treated or cryotherapy patients exhibited lower NT incidence and severity associated with taxane-based chemotherapy than the controls. For patients who can afford and comply with NS use or cryotherapy, these measures represent effective prophylactic management for taxane-induced NT and improve their quality of life and functional statuses. Further studies are needed to establish the routine usage protocols, long-term efficacy and safety for these interventions.

Importance of Sock Type in the Development of Foot Lesions on Low-Difficulty, Short Hikes.

Background and objectives: Foot lesions can be developed during hiking because of external factors. This makes it important to study the effect of hiking equipment on lesion development. Materials and Methods: Technical and non-technical socks were given to 109 hikers to wear during a short hike. Participants were examined at three stages of the hike to determine the development of dermal, muscle and nail lesions, temperature and perimeter in various areas of each foot. Results: The percentage of hikers without injuries was significantly higher among those wearing technical socks (p-value < 0.001). Differences were also observed in mean foot temperature, which was higher in participants wearing technical socks (p-value < 0.001). Conclusion: The results indicate that even on a low-difficulty, short-term sport activity, it is advisable to wear technical socks to prevent lesion development and keep the foot temperature more stable. Sock type was identified as an external conditioning factor in lesion development.

Onicomadesis: un signo de alarma inusual en el anciano / Onychomadesis: an unusual sign of alarm in the elderly

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Treatment and prevention of paronychia using a new combination of topicals: report of 30 cases.

AIM: Moderate and chronic paronychia is a common disease affecting the hand. Treatment can be effective but the affection is often recurrent, especially as an occupational disease. Moreover, this condition may be complicated by a Candida spp or by bacterial infections. Therefore, general preventive measures can be useful in maintaining health. The aim of this study was to investigate the efficacy and tolerability of a new combination of topical medications in the treatment and prevention of moderate and chronic paronychia. This formulation includes an insulating polymer (Syn-cell barrier), two topical antifungals (octopirox and climbazole) and a molecule with anti-inflammatory activity (corticoid-like repair). METHODS: Thirty adult subjects (age, 16-78 years; 24 females and 6 males) affected by moderate or chronic paronychia, with or without nail alterations, were evaluated. Included in the study were patients with allergic contact dermatitis (8), irritant contact dermatitis (19), psoriatic paronychia (2 patients), lichen planus of the nails (1 patient). Sometimes Candida spp or bacteria overlapped with paronychia (16 patients positive for Candida spp and 4 patients with bacterial paronychia), sometimes infectious paronychia was not associated with dermatitis of the hands. All 30 subjects were treated with a new cream formulation, three applications per day for 2 months. In 8 patients with proven and severe candidiasis of the nails, oral fluconazole 100 mg was added for 20 days. All patients with bacterial perionyxis took clarithromycin 500 mg twice daily for six days. Patients were then followed for 8 weeks. RESULTS: After two months of treatment, 26 patients responded to therapy. In particular, the treatment evaluation at the end of the follow-up period showed a clinical cure in 46.6% (14 patients), improvement in 40% (12 patients), and failure in 13.4% (4 patients). There was a side effect (moderate skin irritation) in 2 patients, but the drug was not discontinued. CONCLUSION: Results of the present study, based on its safety, effectiveness and innovative features, indicate that this combination of topical cream may be considered as a new alternative for treatment and prevention of paronychia, especially in case of occupational hand disease where prolonged treatment and continuous prevention are needed.

Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial.

PURPOSE: This study investigated the efficacy and safety of cryotherapy, in the form of frozen gel gloves, in relation to docetaxel-induced hand and fingernail toxicities. PATIENTS AND METHODS: After piloting with 21 patients, a consecutive series sample of patients (n=53) prescribed docetaxel every 3 weeks, for a minimum of three cycles, was enrolled in this randomised control trial. Participants acted as their own control, with the frozen gel glove worn on one randomised hand for 15 min prior to infusion, for the duration of the infusion, and for 15 min of after completion of treatment. Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria. To assess the potential for cross-infection of multi-use gloves, microbial culture and sensitivity swabs were taken of each glove at every tenth use. RESULTS: Of the 53 participants enrolled in the main study, 21 provided evaluable data. There was a 60 % withdrawal rate due to patient discomfort with the intervention. The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma grade 1 (5/5 %), nail discolouration grade 1 (81/67 %), nail loss grade 1 (19/19 %) and nail ridging grade 1 (57/57 %). No significant differences were determined between hand conditions in terms of time to event, nor in terms of toxicity in gloved and non-gloved hands. CONCLUSION: While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe, its limited efficacy, patient discomfort and some logistical issues preclude its use in our clinical setting.

Manejo de la onicocriptosis en atención primaria. caso clínico / Management of onychocryptosis in primary care: a clinical case

La onicocriptosis (uña encarnada) es una enfermedad ungueal de gran demanda en el servicio de atención primaria, molesta y limitante para los pacientes, con gran incidencia en el sexo masculino y en edades comprendidas entre la segunda y tercera décadas de la vida, de etiología indeterminada en la que intervienen una serie de factores tanto desencadenantes como predisponentes. El tratamiento depende del estadio en que se encuentre la uña encarnada e incluye desde procedimientos conservadores hasta intervenciones de cirugía menor que pueden ser realizadas por el médico de atención primaria en el centro de salud. Presentamos el caso clínico de un hombre de 25 años con onicocriptosis que no respondió a un manejo conservador y se realizó una extracción del extremo ungueal con matricectomía parcial (AU)

Onychocryptosis (ingrown toenail) is a condition commonly seen in Primary Care clinics. It is uncomfortable and restrictive for patients and has a high incidence in males between second and third decades of life. It is of unknown origin, with a number of predisposing triggering factors being involved. Treatment depends on the stage of the ingrown nail and the procedures may range from conservative to minor surgery that can be performed by the Primary Care physician in the health centre. We report the case of a 25-year onychocryptosis that did not respond to conservative management, and was extracted with partial matricectomy of the nail (AU)

Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients.

PURPOSE: Frozen gloves (FG) are effective in preventing docetaxel-induced nail toxicity (DNT), but uncomfortable. The preventive effect of FG for DNT was compared using a standard (-25 to -30°C) or more comfortable (-10 to -20°C) preparation. METHODS: Breast cancer patients receiving docetaxel were eligible. Each patient wore an FG (prepared at -10 to -20°C for 90 min) for 60 min without replacement on the right hand. The left hand was protected by standard methods (FG prepared at -25 to -30°C overnight and worn for 90 min with replacement at 45 min). The primary endpoint was DNT occurrence at 5 months. Secondary endpoints included docetaxel exposure [cumulative dose and area under the blood concentration time curve (AUC)] until DNT occurrence and discomfort from FG. The pharmacokinetics of docetaxel was assessed. RESULTS: From 23 patients enrolled between December 2006 and June 2010, seven who received docetaxel for less than 5 months were excluded from evaluation. The median accumulated docetaxel dose was 700 mg/m(2) (340-1430 mg/m(2)). Within 5 months of FG use, none developed protocol-defined DNT in either hand. Two patients (13%) developed DNT at 7.2 and 7.3 months, respectively, both at -10 to -20°C. In the control hand (-25 to -30°C), discomfort occurred in 92% of the cycles, compared to 15% in the experimental hand (-10 to -20°C). Five patients (22%) experienced pain at -25 to -30°C, but none did at -10 to -20°C. The degree of docetaxel exposure was not related to DNT occurrence in our study. CONCLUSION: A convenient preparation of FG at -10 to -20°C is almost as effective as a standard preparation at -25 to -30°C, with significantly less discomfort.

Taxane-induced nail changes: Predictors and efficacy of the use of frozen gloves and socks in the prevention of nail toxicity.

PURPOSE: The primary endpoint of this study was to determine predictors of taxane-related nail toxicity. The secondary endpoint was to evaluate the efficacy of the use of frozen gloves and socks in the prevention of taxane-related nail toxicity. METHODS: This descriptive, interventional, cross-sectional study was conducted with 200 patients. The patients were assigned to the frozen gloves/socks intervention group or control group. Frozen gloves/socks were applied only in hourly taxane-based treatments. The Patients Record Forms of the clinic were used in data collection. Nail changes were graded using the NCI Common Toxicity Criteria for each patient and treatment. Logistic regression analysis was performed to predict the factors that affect nail changes. RESULTS: The majority of the patients enrolled in the study were women diagnosed with breast cancer. The two groups were statistically similar for the cancer diagnosis, type and number of taxane cycles administered. Grade 1 nail toxicity was found in 34%, grade 2 in 11%, and grade 3 in 5.5% patients. Taxane-related nail toxicity was higher in patients who were female, had a history of diabetes, received capecitabine in conjunction with docetaxel and had breast or gynecological cancer diagnosis. Nail changes increased with an increase in the number of taxane cycles administered, BMI and severity of treatment-related neuropathy. CONCLUSIONS: The multivariate analysis demonstrated that BMI, breast or ovarian cancer diagnosis and the number of taxane cycles administered were the independent factors for this toxicity. No statistically significant difference in nail toxicity incidence and time to occurrence of nail changes was found between the intervention and the control groups.