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
• Interventions: Other: Moisturising cream with vitamin E concentrate; Other: Moisturising cream without vitamin E concentrate; Other: Urea cream

• 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.

Study Timeline

• Study Start: 2023-05-16
• Study First Submitted: 2023-06-25
• Study First Submitted QC: 2023-07-02
• Study First Posted: 2023-07-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-08-31
• Study Completion: 2025-11-30

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

Arm && Interventions

Group	Intervention	Description
Moisturising Cream without Vitamin E and Urea Cream	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.
Moisturising Cream with Vitamin E and Urea Cream	Moisturising cream with vitamin E concentrate	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.
Moisturising Cream with Vitamin E and Urea Cream	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.
Moisturising Cream without Vitamin E and Urea Cream	Moisturising cream without vitamin E concentrate	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.
Urea Cream Only	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.

Primary Outcome Measures

Name	Time	Method
Palmar-plantar erythrodysesthesia (PPE) resolution	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)

Secondary Outcome Measures

Name	Time	Method
Time-to-PPE resolution	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
Overall adverse events	At Day 22, Day 43, Day 64, and Day 127 of cream treatment	Frequency of overall adverse events
Palmar-plantar erythrodysesthesia (PPE) worsening	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)
Time-to-PPE worsening	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
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 events	At 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