Immersive virtual reality improves several side effects during paclitaxel/carboplatin or paclitaxel/carboplatin plus bevacizumab therapy: A two-arm randomized controlled trial.

Abstract

Background: Symptomatic drug treatment is generally used to treat various side effects associated with paclitaxel/carboplatin (TC) or TC plus bevacizumab (TC+Bev). However, this can lead to increased adverse effects from additional drugs. Immersive virtual reality (iVR) reduces pain and anxiety.

Objective: This study aimed to investigate the efficacy of iVR in managing side effects associated with TC or TC+Bev therapy.

Methods: This two-arm randomized controlled trial included patients with gynecologic cancer scheduled to undergo their first course of TC/TC+Bev. Patients in the intervention group received iVR for approximately 10 min/day for 7 consecutive days, starting on the first day of treatment. The primary endpoint was the severity of physical and psychiatric symptoms measured using the Japanese version of the revised Edmonton Symptom Rating System (ESAS-r-J). The secondary endpoint included the proportion of patients who used additional antiemetic medications, the complete response (CR) rate to nausea and the severity of anxiety, measured using the state-trait anxiety inventory-JYZ (STAI) Y-1. Patients in the non-intervention group received supportive and symptomatic treatments.

Results: The analysis included 28 and 30 patients in the intervention and non-intervention groups, respectively. The change in ESAS-r-J scores between days 1 and 7 and nausea were significantly worse in the intervention group on day 4 only (p<0·001); however, the non-intervention group showed significantly worse scores on days 3, 4, and 5. Depression was not significantly worse in the intervention group on any day other than on day 1; however, the non-intervention group showed significantly worse scores on day 4. The proportion of patients who used additional antiemetic medications from days 2 to 7 was significantly lower in the intervention group than in the non-intervention group (p=0.024). Regarding the change in STAI Y-1 on day 1 of TC or TC+Bev therapy, the mean score was significantly lower after the iVR experience than before the experience in the intervention group (from 43.8 to 34.8, p<0.001), whereas in the non-intervention group, no significant difference was observed before and after anticancer drug administration (from 44.9 to 43.9, p=0.536).

Conclusions: iVR may reduce deterioration of nausea and depression more effectively in patients with gynecologic cancer undergoing TC or TC+Bev therapy than in those undergoing non-intervention, especially in delaying the onset of nausea and accelerating recovery.

Clinicaltrial: UMIN Clinical Trials Registry (UMIN000041067; https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000046892).