437P - A randomized single blinded phase II trial comparing efficacy and quality of life of topical aloe vera gel plus urea cream versus urea cream alone for prevention of hand-foot syndrome in cancer patients receiving capecitabine

Background

Capecitabine is an oral antimetabolite chemotherapy apply for various types of cancers. One of the most common adverse events of capecitabine is hands-foot-syndrome (HFS). The incidence of HFS is generally about 50%-60%, while grade 3 toxicity occurs about 10%-20%. Interrupting capecitabine due to adverse events improve symptoms but may decrease efficacy of treatment. Products with aloe-vera component was introduced in many studies and showed efficacy in improvement of skin problems. Aloe vera gel with urea cream combination may increase efficacy in HFS for prevention and treatment.

Methods

The study was a randomized single-blinded phase II study. The screening and randomization began in December 2021 until January 2023. Patients who diagnosed with cancer that appropriated for receiving capecitabine were randomized 1:1 by using the block of four. The treatment group received both aloe vera gel and 10% urea cream, while controlled group received 10% urea cream. The sample size was calculated using 90% power to show a 20% reduction of the incidence of HFS grade 2-3 with aloe vera gel plus urea cream. The significant p-value was p-value <0.05.

Results

There were 61 patients in this study. Patients in both groups had a good compliance. There were 30 patients in aloe vera plus 10% urea cream group and 31 patients in 10% urea cream group. In aloe vera plus 10% urea cream group, there are 86.7% in grade 0-1 HFS and 13.3% in grade 2-3 HFS, while in 10% urea cream group, there are 64.5% in grade 0-1 HFS and 35.5% in grade 2-3 HFS, p-value was 0.045.There are statistically significant lower grade 2-3 of HFS in aloe vera and 10% urea cream combination arm. Table: 437P

Severity of HFS

Conclusions

Combination aloe vera gel to 10% urea cream decrease the incidence of grade 2-3 HFS in cancer patients being treated with capecitabine. No statistical difference in quality of life according to DLQI between two groups.

Clinical trial identification

TCTR20230411005.

Editorial acknowledgement

Legal entity responsible for the study

Department of internal medicine, Faculty of Medicine, Vajira hospital, Navamindradhiraj University.

Funding

The present study was supported by the Navamindradhiraj University Research Fund. This study was approved by Vajira institutional Review Board (COA 236/2564).

Disclosure

All authors have declared no conflicts of interest.