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

Not Applicable
Recruiting
Conditions
Palmar-Plantar Erythrodysesthesia
Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy
Registration Number
NCT05939726
Lead Sponsor
Sarawak General Hospital
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Palmar-plantar erythrodysesthesia (PPE) resolutionAt 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)

Secondary Outcome Measures
NameTimeMethod
Time-to-PPE resolutionAt Day 22, Day 43, Day 64, and Day 127 of cream treatment

Time-to-PPE resolution via patient self-reported symptoms in standardised diary

Overall adverse eventsAt Day 22, Day 43, Day 64, and Day 127 of cream treatment

Frequency of overall adverse events

Palmar-plantar erythrodysesthesia (PPE) worseningAt 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)

Time-to-PPE worseningAt Day 22, Day 43, Day 64, and Day 127 of cream treatment

Time-to-PPE worsening via patient self-reported symptoms in standardised diary

Pain score (numerical scale of 1 to 10)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.

Dermatology-related adverse eventsAt Day 22, Day 43, Day 64, and Day 127 of cream treatment

Frequency of dermatology-related adverse events

Dermatology Life Quality Index (0 - 30)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.

Trial Locations

Locations (1)

Sarawak General Hospital

🇲🇾

Kuching, Sarawak, Malaysia

Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Hie Ung Ngian, M.D.
Contact
6082243401
ngianhu@moh.gov.my

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