Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of taxanes, with no effective prevention or treatment available and a highly negative impact on patient quality of life. The aim of this study is to asses that the constant application of cooled cuffs on the hands and feet prevent and mitigate CIPN. METHODS: Patients with breast, gynecologic, and pancreatic cancer who received weekly paclitaxel (PTX), PTX/carboplatin, and nab-paclitaxel (nab-PTX)/gemcitabine for any indication at the therapeutic scheduled dosage were included in this prospective study. Hilotherm Chemo care device forms a closed-loop system with cuffs and tubes through which a coolant flows at a temperature of 10 °C. CIPN was monitored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (edition 3.0), and the tolerability and side effects were scored by using the Common Terminology Criteria for Adverse Events (T4.03 2017). RESULTS: To date, we have enrolled 64 patients. Of these, 54 (84%) completed all cooling cycles. Continuous cooling was well tolerated by all patients. No patients had grade >2 CIPN or had serious or lasting adverse events as a result of Hilotherapy. The median time to CIPN onset was 77 days for the entire population. CONCLUSION: Hilotherapy has good effectiveness and tolerability and seems to be able to prevent or reduce the symptoms of CIPN. We are still recruiting patients to obtain more data and to collect data at 3 months after the end of chemotherapy. Prospective studies seem to be warranted.

Hilotherapy for the management of perioperative pain and swelling in facial surgery: a systematic review and meta-analysis.

Hilotherapy is the application of cold compression at a regulated temperature through a face mask. Studies that have evaluated its efficacy have focused on postoperative oedema, pain, and the patient's comfort. However, there is no clear consensus in favour of its use, so we have made a systematic review and meta-analysis to evaluate relevant published reports. We searched PubMed, EMBASE, MEDLINE, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials to identify studies. Sixty-one records were screened, six of which met the inclusion criteria and four of which were suitable for meta-analysis. All data suitable for meta-analysis were derived from studies of elective and traumatic facial skeletal surgery. Hilotherapy was associated with significant reductions in facial pain on postoperative day 2 (p<0.00001), and facial oedema on days 2 (p=0.0004) and 3 (p=0.02). Patients reported more comfort and satisfaction with hilotherapy than with cold compression (p<0.00001). The effect of hilotherapy on ecchymosis and formation of haematomas remains uncertain. Well-designed, randomised, controlled trials of its use after aesthetic facial surgery are required.

Systematic review and meta-analysis of the efficacy of hilotherapy following oral and maxillofacial surgery.

Craniofacial surgery causes immediate postoperative pain, oedema, and functional limitations. Hilotherapy delivers cooled water to the face at 15°C and may reduce the postoperative recovery time. This work presents a meta-analysis of short-term postoperative outcomes after hilotherapy. Following a systematic literature search, comparative trials of patients undergoing surgical interventions in the maxillofacial region and receiving either hilotherapy or ice-cooling therapy were included for meta-analysis. Demographics and surgical outcomes were extracted. Data were analysed using Comprehensive Meta-Analysis software. Mean (SEM) data were calculated for demographic variables and standardized mean differences with the 95% confidence interval for surgical outcomes. Five trials were analysed, providing 206 patients for evaluation; mean patient age was 29.4 (9.4) years. Hilotherapy reduced pain (10-point visual analogue scale) at 48 h (P<0.010) and 72 h (P<0.050), as well as postoperative facial oedema (P<0.010), compared to ice-cooling treatment. Trismus and facial neurological scores were also improved (P=0.08). Patients preferred hilotherapy to other cooling methods (P<0.010). Hilotherapy appears to be effective in reducing postoperative facial pain, oedema, and trismus, and in improving patient-reported outcomes. Well-designed randomized controlled clinical trials are required to clarify the procedure-specific efficacy of postoperative hilotherapy and optimal durations of treatment.

Temperature-controlled continuous cold flow device versus traditional icing regimen following anterior cruciate ligament reconstruction: a prospective randomized comparative trial.

INTRODUCTION: Anterior cruciate ligament (ACL) reconstruction requires an intensive rehabilitation program to be completely successful. Cryotherapy has been described to be helpful in reducing post-operative pain and edema. Aim of this prospective randomized study is to compare two homogeneous groups of patients, one receiving traditional icing regimen and the other a temperature-controlled continuous cold flow device, in post-operative setting after ACL reconstruction. MATERIALS AND METHODS: Forty-seven patients treated for ACL reconstruction using "over the top" technique were enrolled for this study. All patients received the same elastocompressive bandage. Regarding the coolant device, 23 patients were randomized to temperature-controlled continuous cold flow device (Hilotherm® group) and 24 patients were randomized to receive ice bag (control group). The two groups were homogenous for pre-operative (age, sex, and time "lesion to surgery") and intra-operative parameters (duration of the procedure, meniscectomy, and chondral damage). NRS (numeric rating scale), blood loss, knee volume increase at three established sites, ROM, and pain killers consumption were assessed. The subjective evaluation of the device including practicality and usefulness of the device was investigated. RESULTS: Hilotherm group resulted in lower pain perception (NRS), blood loss, knee volume increase at the patellar apex and 10 cm proximal to the superior patellar pole, and higher range of motion (p < 0.05) in the first post-operative day. No difference in pain killers consumption was noted. Hilotherm device was considered "comfortable" and "useful" by the majority of patients. CONCLUSIONS: Hilotherm group showed significant better results in first post-operative day. Further studies with higher number of patients and longer follow-up are required to assess the beneficial effects on rehabilitation and the cost-effectiveness of the routinely use of this device. LEVEL OF EVIDENCE: II.