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

January 12, 2026 updated by: Voon Pei Jye, Sarawak General Hospital

A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years old and above
  2. Able to give written consent freely
  3. Receiving capecitabine 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moisturising Cream with Vitamin E and Urea Cream
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
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.
Other: Urea cream
Urea cream (10%w/w) is used as the standard of care for PPE.
Experimental: Moisturising Cream without Vitamin E and 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: Urea cream
Urea cream (10%w/w) is used as the standard of care for PPE.
Other: Moisturising cream without vitamin E concentrate
This moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate
Active Comparator: Urea Cream Only
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
Urea cream (10%w/w) is used as the standard of care for PPE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palmar-plantar erythrodysesthesia (PPE) resolution
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Number of participants who have resolved PPE (NCI-CTCAE grade 1 to 0)
At Day 22, Day 43, Day 64, and Day 127 of cream treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palmar-plantar erythrodysesthesia (PPE) worsening
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Number of participants who have worsened PPE (NCI-CTCAE grade 1 to 2/3)
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE resolution
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE resolution via patient self-reported symptoms in standardised diary
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE worsening
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE worsening via patient self-reported symptoms in standardised diary
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology Life Quality Index (0 - 30)
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
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.
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Pain score (numerical scale of 1 to 10)
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
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.
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Overall adverse events
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Frequency of overall adverse events
At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology-related adverse events
Time Frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Frequency of dermatology-related adverse events
At Day 22, Day 43, Day 64, and Day 127 of cream treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarawak General Hospital

Collaborators

Universiti Sains Malaysia
Avantsar Sdn. Bhd.

Investigators

  • Principal Investigator: Pei Jye Voon, M.D, Sarawak General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

June 20, 2025

Study Registration Dates

First Submitted

June 25, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC005-ECaPPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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