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

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/m 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.