Abstract 470TiP
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.
Resources from the same session
270P - Germline BRCA1/2 pathogenic variants in Japanese patients with prostate cancer are predictive factors for androgen receptor-axis-targeted therapy or chemotherapy for castration-resistant prostate cancer
Presenter: Shigekatsu Maekawa
Session: Poster Display
Resources:
Abstract
271P - Prostate cancer with histone modifier UTX mutations can benefit from olaparib
Presenter: NOBUHITO MURAMOTO
Session: Poster Display
Resources:
Abstract
272P - Comparison between MRI-targeted and standard biopsy for prostate cancer detection: A systematic review and meta-analysis
Presenter: Andree Kurniawan
Session: Poster Display
Resources:
Abstract
273P - The diagnostic performance of cognitive MRI-targeted biopsy in biopsy-naïve patients undergoing systematic 14-region 18-core biopsy: Do the three areas affect the results?
Presenter: Yuka Toyama
Session: Poster Display
Resources:
Abstract
274P - Index tumor location influencing early biochemical recurrence after radical prostatectomy in patients with negative surgical margins
Presenter: Jun Akatsuka
Session: Poster Display
Resources:
Abstract
275P - Prognosis of metastatic castration-resistant prostate cancer in response to chemotherapy and PSMA expression in circulating tumor cells
Presenter: Naoya Nagaya
Session: Poster Display
Resources:
Abstract
276P - Prognostic significance of p53 mutation in metastatic hormone-sensitive prostate cancer
Presenter: Lakshmi Kamala
Session: Poster Display
Resources:
Abstract
277P - Vasohibin-1 expression as a biomarker of aggressive growth in prostate ductal adenocarcinoma
Presenter: Murad Salomov
Session: Poster Display
Resources:
Abstract
278P - Full-coverage radiotherapy for prostate cancer patients with oligometastases
Presenter: Bichun Xu
Session: Poster Display
Resources:
Abstract
279P - Hypofractionated radiotherapy protocol implementation and early outcomes for prostate cancer patients: A single institution retrospective review
Presenter: Thu Nguyen
Session: Poster Display
Resources:
Abstract