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
26P - Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China
Presenter: Bei Sun
Session: Poster Display
Resources:
Abstract
27P - The biological characteristics of HER2-low in TNBC using mRNA profiling and molecular subtypes
Presenter: Asako Tsuruga
Session: Poster Display
Resources:
Abstract
28P - One-week ultra-hypofractionated partial breast RT in early breast cancer: 3DCRT vs IMRT
Presenter: Nurilla Zaynutdinov
Session: Poster Display
Resources:
Abstract
30P - Stereotactic body radiotherapy using cyberknife versus interstitial brachytherapy in accelerated partial breast irradiation on left-sided breast: A comparison of preliminary clinical result and dosimetric characteristics
Presenter: Ting-Na Wei
Session: Poster Display
Resources:
Abstract
31P - Prognostic implication of breast edema on preoperative breast MRI in breast cancer
Presenter: Ki-tae Hwang
Session: Poster Display
Resources:
Abstract
32P - Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study
Presenter: Manami Tada
Session: Poster Display
Resources:
Abstract
34P - Social support as the mediator of the association between unmet needs and happiness among women with early breast cancer
Presenter: Nithiya Sinarajoo
Session: Poster Display
Resources:
Abstract
35P - Prospective study assessing the efficacy and safety of a scalp cooling device for the prevention of alopecia in breast cancer patients undergoing (neo)adjuvant chemotherapy
Presenter: Winnie Yeo
Session: Poster Display
Resources:
Abstract
37P - To excise or not to excise: Preventive management of early breast cancer in atypical ductal hyperplasia patients
Presenter: Clarisse Hing
Session: Poster Display
Resources:
Abstract
38P - Exploring prognostic factors in patients achieving PCR after neoadjuvant therapy for triple-negative breast cancer: A retrospective study based on SEER data
Presenter: Lv Wenjie
Session: Poster Display
Resources:
Abstract