An interventional study of Moisturising cream with vitamin E concentrate and Moisturising cream without vitamin E concentrate in Palmar-Plantar Erythrodysesthesia and Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy, sponsored by Sarawak General Hospital. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Sarawak General Hospital · Not applicable, Interventional, and Treatment
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.
In this study, cancer patients from Sarawak General Hospital who are receiving capecitabine-based therapy and develop PPE of NCI-CTCAE grade 1 will be recruited and randomised 1:1:1 to three study arms. The participants who are randomised to treatment arms will receive moisturising creams with or without palm-oil-derived vitamin E concentrate, in addition to urea-based cream for external application on palms and soles. Participants who are randomised to the control arm will be required to use urea-based cream only.
Both patients and investigators will be blinded to the investigational cream assignment i.e., double-blind. However, blinding will not be applicable to the use of urea cream i.e., open-label. The patients will need to use the cream(s) at least two times a day for nine to eighteen weeks or equivalent to three to six treatment cycles of capecitabine. At week-9, the patients who are planned to continue capecitabine therapy and do not develop PPE of grade 2/3 will continue to receive the study treatments for additional nine weeks or equivalent to three treatment cycles of capecitabine (extended period).
The patients will be assessed for their PPE grading, symptoms, dermatological quality of life, pain score, and adverse events at the end of each capecitabine treatment cycle at the clinic.
Exclusion Criteria:
Participants who are randomised in this arm will receive a moisturising cream containing palm-oil-derived vitamin E concentrate for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day.
Other: Moisturising cream with vitamin E concentrate · Other: Urea cream
Participants who are randomised to this arm will receive a basic or plain moisturising cream without Vitamin E for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day.
Other: Moisturising cream without vitamin E concentrate · Other: Urea cream
Participants who are randomised to this arm will receive urea-based cream only as the standard of care for PPE management. They will be required to use the urea cream at least twice a day.
Other: Urea cream
The vitamin E moisturising cream contains 3% w/w of palm-oil-derived vitamin E concentrate, consisting of the following isomers: alpha-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol, and delta-tocotrienol. This formula provides a total of 1.2g tocotrienols per 100g product.
This moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate
Urea cream (10%w/w) is used as the standard of care for PPE.
Palmar-plantar erythrodysesthesia (PPE) resolution
Number of participants who have resolved PPE (NCI-CTCAE grade 1 to 0)
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Palmar-plantar erythrodysesthesia (PPE) worsening
Number of participants who have worsened PPE (NCI-CTCAE grade 1 to 2/3)
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE resolution
Time-to-PPE resolution via patient self-reported symptoms in standardised diary
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE worsening
Time-to-PPE worsening via patient self-reported symptoms in standardised diary
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology Life Quality Index (0 - 30)
The Dermatology Life Quality Index (DLQI) consists of 10 questions, and each question is assigned a score (0 to 3). The total score ranges from 0 to 30, with higher scores indicating greater impairment in the individual's quality of life.
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Pain score (numerical scale of 1 to 10)
The pain score is assessed using a 1-10 numeric rating pain scale, where 1 represents no pain at all, and 10 is the worst pain.
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Overall adverse events
Frequency of overall adverse events
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology-related adverse events
Frequency of dermatology-related adverse events
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Sarawak General Hospital