KEY TAKEAWAYS
- The ECaPPE study aims to investigate the efficacy of a moisturizing cream with or without palm-oil-derived vitamin E concentrate.
- The primary endpoint is to achieve the resolution of PPE.
- Researchers noticed significant progress in the trial and additional outcomes will be provided later.
Palmar-plantar erythrodysesthesia (PPE), a common adverse reaction to capecitabine, significantly impacts patients’ (pts) daily lives due to its painful and debilitating nature. Currently, there is no established treatment for PPE, with dose modification and treatment interruption being the primary approaches.
Urea cream has demonstrated efficacy in preventing and mitigating PPE in various studies, forming a standard of care. While oral vitamin E has shown promise in small observational studies, the role of topical vitamin E in PPE management remains unexplored. Notably, PPE often originates from dry skin.
Pei Jye Voon and his team aimed to investigate the impact of moisturizing cream, with or without palm-oil-derived vitamin E concentrate in addition to urea cream, compared to urea cream alone.
The study was performed as a single-centered, three-arm, randomized controlled trial at Sarawak General Hospital, Malaysia. About 90 pts will be enrolled and randomly assigned to three study arms in a 1:1:1 ratio. Both pts and the study team will be blinded to the investigational moisturizing cream assignment, ensuring a double-blind design. However, the group using urea-based cream alone will be open-label. Participants are required to apply the cream(s) twice daily for nine to eighteen weeks, equivalent to three to six capecitabine-based treatment cycles. The primary endpoint is the resolution of hand-foot syndrome (PPE) from grade 1 to 0. Secondary endpoints include preventing worsening of PPE (grade 1 to 2/3), time-to-PPE resolution/worsening, Dermatology Life Quality Index, and pain score. Currently, 20 out of 90 patients have been recruited.
This research will provide valuable insights into potential advancements in PPE management, ultimately contributing to enhanced patient well-being. The trial is ongoing, and results are yet to be presented.
The study is sponsored by Sarawak General Hospital
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/78
Clinical Trial: https://clinicaltrials.gov/study/NCT05939726
Voon P J, King T L , Lim X Y, et al. (2023). “TiP – Randomised controlled trial to evaluate the efficacy and safety of moisturizing creams with or without palm-oil-derived vitamin E concentrate in addition to urea-based cream or urea-based cream alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE).” Presented at ESMO ASIA 2023 (Abstract 470).
