Efficacy and Safety of Moisturising Cream With or Without Vitamin E and Urea Cream in Palmar-plan… (NCT05939726) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Moisturising Cream With or Without Vitamin E and Urea Cream in Palmar-plantar Erythrodysesthesia
Malaysia145 participantsStarted 2023-05-16
Plain-language summary
This is a single-centre, phase II, three-arm, randomised controlled trial to evaluate the efficacy and safety of a cosmetic moisturising cream containing palm-oil-derived vitamin E concentrate or a similar moisturising cream without the vitamin E concentrate in addition to urea-based cream, or urea-based cream alone (1:1:1) in patients who are receiving capecitabine-based cancer therapy and develop capecitabine-associated PPE of NCI-CTCAE grade 1.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years old and above
✓. Able to give written consent freely
✓. Receiving capecitabine at least 1 dose, as monotherapy or in combination therapy
✓. Receiving urea-based cream
✓. Developed PPE of NCI-CTCAE grade 1
✓. Have at least three cycles of chemotherapy to complete
✓. Life expectancy ≥ 6 months
✓. ECOG≤2
Exclusion criteria
✕. Unable to understand the information sheet and informed consent form
✕. Allergy history towards vitamin E and its isoforms or any components of the investigational products
✕. Unable to tolerate urea-based products
✕. Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
✕. PPE complicated with infection
✕. Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions