Efficacy and Safety of Moisturising Cream With or Without Vitamin E and Urea Cream in Palmar-plantar Erythrodysesthesia

Overview

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.

Description

In this study, 90 cancer patients from Sarawak General Hospital who are receiving capecitabine-based therapy (2000-2500mg daily dose) 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.

Eligibility

Inclusion Criteria:

1. 18 years old and above
2. Able to give written consent freely
3. Receiving capecitabine at 2000-2500mg/m2/day or 1000-1250/m2/dose twice a day, at least 1 dose, as monotherapy or in combination therapy
4. Receiving urea-based cream
5. Developed PPE of NCI-CTCAE grade 1
6. Have at least three cycles of chemotherapy to complete
7. Life expectancy ≥ 6 months
8. ECOG≤2

Exclusion Criteria:

1. Unable to understand the information sheet and informed consent form
2. Allergy history towards vitamin E and its isoforms or any components of the investigational products
3. Unable to tolerate urea-based products
4. Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
5. PPE complicated with infection
6. Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions
7. Receiving long-term topical or systemic steroid treatment (except as part of pre-or post-medications of chemotherapy regime)
8. Pregnant or lactating mother
9. Participating in another interventional trial
10. Refuses to interrupt his/her usual care
11. Anticipated inability to follow-up