470TiP - Randomised controlled trial to evaluate the efficacy and safety of moisturising 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)

Background

Palmar-plantar erythrodysesthesia (PPE) is a typical adverse cutaneous reaction associated with capecitabine. PPE can be painful and debilitating, interfering with patients’ daily functions and impacting their quality of life. There is no effective treatment for PPE except dose modification and treatment interruption. Besides that, urea cream has been proven to be effective in preventing the occurrence and worsening of PPE in several studies and it is used as part of the standard of care for PPE. Vitamin E possess anti-inflammatory and antioxidant properties and has been used to treat a variety of skin conditions. Although oral vitamin E has been shown to be effective in treating PPE in small observational studies, there is no study done on the use of topical vitamin E in PPE management. We also noted patient with PPE typically starts with dry skin. Therefore, in the current study, we aim to determine the effect of moisturising cream with or without palm-oil-derived vitamin E concentrate in addition to urea cream versus urea cream alone in patients receiving capecitabine-based treatment and developed NCI-CTCAE grade 1 PPE.

Trial design

This is a single-centred, three-arm, randomised controlled trial in patients from Sarawak General Hospital, Malaysia. In this study, 90 patients will be enrolled and randomised to three study arms (1:1:1). Both patients and study team will be blinded to the investigational moisturising cream assignment i.e. double-blind. However, the group that uses urea-based cream only will be open-label. The patients will need to use the cream(s) twice a day daily for nine to eighteen weeks or equivalent to three to six treatment cycles of the capecitabine-based regime. The primary endpoint is resolution of PPE (grade 1 to 0). The secondary endpoints are prevention of worsening of PPE (grade 1 to 2/3), time-to-PPE resolution/worsening, Dermatology Life Quality Index, and pain score. We have currently recruited 20 out of 90 patients.

Clinical trial identification

NCT05939726.

Legal entity responsible for the study

The authors.

Funding

1. Avantsar Sdn Bhd 2. Ministry of Health Malaysia.

Disclosure

K.H. Yuen: Financial Interests, Institutional, Full or part-time Employment: Sarawak Palm Oil Berhad. All other authors have declared no conflicts of interest.