Use of glucose solution for the alleviation of gemcitabine-induced vascular pain: a double-blind randomized crossover study.

PURPOSE: Gemcitabine is widely used for chemotherapy in many types of cancers. However, vascular pain frequently occurs during its infusion, which can be serious enough to cause treatment discontinuation. This study was conducted to determine whether dissolution with 5 % glucose solution would relieve vascular pain compared with the approved use of saline as the diluent.
METHODS: Patients with cancer who were treated with weekly gemcitabine were eligible. Vascular pain was assessed during two consecutive administrations in a double-blind, randomized crossover study. One group was scheduled to receive gemcitabine dissolved in saline followed by gemcitabine in 5 % glucose solution. In the other group, 5 % glucose solution was followed by saline. The primary endpoint was frequency of vascular pain for the total infusions of each solvent and the secondary endpoints were intensity, as assessed on a visual analogue scale and duration of vascular pain.
RESULTS: Eighty-seven patients were randomly assigned to each treatment schedule. Frequency of vascular pain was significantly lower with 5 % glucose solution compared with saline (40 versus 63 %; p < 0.001). The intensity of vascular pain was also reduced with 5 % glucose solution compared with saline (mean, 1.3 versus 2.7 points; p < 0.001). There was no significant statistical difference in duration of vascular pain between the 5 % glucose solution and saline solution groups (mean, 21 versus 18 min; p = 0.420).
CONCLUSIONS: The use of 5 % glucose solution to dissolve gemcitabine significantly reduced the frequency and the intensity of vascular pain compared with the use of saline.

RCT Entities:   Population Interventions Outcomes