Efficacy of Siriraj, in-house-developed, frozen gloves for cold therapy reduction of chemotherapy-induced peripheral neuropathy in gynecological cancer patients: randomized controlled trial

Abstract

Objectives The primary objective of this study was to investigate the efficacy of cold therapy in reducing paclitaxel-based, chemotherapy-induced, peripheral neuropathy (CIPN). The secondary objective was to establish the incidence of CIPN arising from paclitaxel administration. Materials and methods The study enrolled gynecological cancer patients who were aged over 18 years and receiving chemotherapy which included paclitaxel (175 mg/m2 every 3 weeks). The patients were allocated to control and cold-therapy groups by computer randomization. During paclitaxel administration, frozen gloves developed in-house by Siriraj Hospital were worn—with a cold pack inside—on both hands and both feet by the cold-therapy patients. The CIPN incidence was evaluated by FACT/GOG-Ntx (version 4) at each chemotherapy cycle and at the 1-month follow-up after treatment completion. Results There were 79 patients (control arm, 40; study arm, 39). The CIPN incidences in the control and cold-therapy groups were 100% and 48.7%, respectively. CIPN was significantly decreased in the intervention group between the first cycle and the 1 month follow-up after chemotherapy cessation (P value < 0.001). Four patients discontinued the cold therapy due to pain, but there were no serious adverse effects due to the therapy. Conclusion The Siriraj Hospital, in-house-developed, frozen gloves can reduce CIPN effectively as part of cold therapy for paclitaxel-based chemotherapy. The benefits of using the gloves are apparent from the first chemotherapy cycle to the 1-month, post-treatment follow-up assessment.

Non-pharmacological therapy for chemotherapy-induced peripheral neurotoxicity: a network meta-analysis of randomized controlled trials

“…Additionally, four studies used interventions pooled as ME [ 28 , 33 , 34 , 37 ], and 13 studies used interventions pooled as UCP. One three-arm trial [ 31 ] conducted a direct comparison of sensorimotor training (SMT), WBV, and UCP, two used cryotherapy [ 32 , 38 ], six used Acu [ 25 , 30 , 35 , 36 , 39 , 40 ] and one used ultrasound and multicomponent exercise (USME [ 34 ]). The close loop of the network map was formed by SMT, WBV, and UCP.…”

“…Subgroup analysis was performed by different scales. Among the studies, 15 applied the FACT/GOG-Ntx subscale for assessment [15,25,28,[30][31][32][33][34][35][36][37][38][39][40][41], involving 667 participants. A higher score of this subscale indicated more mild neuropathological symptoms.…”

Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer

“…6,8 One prospective randomized trial in gynecologic cancer found that cryotherapy significantly reduced subjective chemotherapy-induced neuropathy using the FACT/ GOG-NTX. 24 Compression alone has been evaluated in breast cancer and resulted in significantly reduced neuropathy compared with no intervention. 25 Another study in breast cancer compared cryotherapy to compression therapy and found no difference in the incidence of peripheral neuropathy.…”

Chemotherapy-induced peripheral neuropathy in children and adolescent cancer patients

“…Thermal therapies such as frozen gloves have been investigated primarily for their preventive effects. Thermoregulatory effects delivered by cryocompression were well-tolerated and were found to significantly reduce the incidence of CIPN (Bandla et al, 2020;Oneda et al, 2020;Chitkumarn et al, 2022). One study has investigated the benefit of combination therapy and implemented a 15-week integrated program of massage, passive mobilization and physical exercises with or without whole body vibration and patients reported less pain and improved function over time (Schönsteiner et al, 2017).…”