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
441P - The prophylactic efficacy of telpegfilgrastim, a Y-shape branched pegylated G-CSF in patient with chemotherapy-induced neutropenia: A multicenter, randomized phase III study
Presenter: Xinshuai Wang
Session: Poster Display
Resources:
Abstract
442P - Negative impact on bone homeostasis in postmenopausal women with non-metastatic breast cancer during cytotoxic chemotherapy
Presenter: Yadav Nisha
Session: Poster Display
Resources:
Abstract
443P - Efficacy of vitamin D supplementation in overall survival of cancer patients: Systematic review and meta-analysis
Presenter: Visakha Irawan
Session: Poster Display
Resources:
Abstract
444P - Commencing a nurse led symptom and urgent review clinic (SURC) in a Victorian regional cancer centre
Presenter: Sue Bartlett
Session: Poster Display
Resources:
Abstract
445P - Self-reported symptom burden, quality of life and unmet need of symptom management in nasopharyngeal cancer survivors: A cross-sectional survey
Presenter: Jerry Ching
Session: Poster Display
Resources:
Abstract
446P - A single center experience of anamorelin in patients with non-small cell lung cancer
Presenter: Takanori Ito
Session: Poster Display
Resources:
Abstract
447P - Quality of life in patients with EGFR-mutated lung cancer receiving gefitinib vs gefitinib plus pemetrexed and carboplatin chemotherapy
Presenter: Nandini Menon
Session: Poster Display
Resources:
Abstract
448P - Association of clinicopathological characteristics and pro-inflammatory markers with reduced relative dose intensity in breast cancer chemotherapy
Presenter: Susanna Hutajulu
Session: Poster Display
Resources:
Abstract
449P - Psychometric validation of the MD Anderson symptom inventory head&neck module: Chinese version in nasopharyngeal cancer survivors
Presenter: Victor Tam
Session: Poster Display
Resources:
Abstract
450P - Retrospective study of anamorelin therapy for unresectable or recurrent pancreatic cancer with cancer cachexia
Presenter: Mao Okada
Session: Poster Display
Resources:
Abstract