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A Randomized Single Blinded Phase II Trial Comparing Efficacy and Quality of Life of Topical Aloe Vera Gel plus Urea Cream versus Urea Cream Alone for Prevention of Hand Foot Syndrome in Cancer Patients Receiving Capecitabine

A Randomized Single Blinded Phase II Trial Comparing Efficacy and Quality of Life of Topical Aloe Vera Gel plus Urea Cream versus Urea Cream Alone for Prevention of Hand Foot Syndrome in Cancer Patients Receiving Capecitabine

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230411005
Enrollment
66
Registered
2023-04-11
Start date
2021-12-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The efficacy of aloe-vera gel with 10% urea cream on HFS compared with 10% urea-cream alone as the primary end point. Hand Foot Syndrome, Aloe vera, Capecitabine, DLQI

Interventions

Add aloe vera gel in combination with 10% urea cream applied per hands and feet,10% urea cream applied per hands and feet as standard of care
Active Comparator Drug,Active Comparator Drug
aloe vera gel in combination with 10% urea cream ,10% urea cream

Sponsors

Navamindradhiraj University Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients at least 18 years of age. 2. patients diagnosed with cancers whose treatment need to be with capecitabine, either single capecitabine or with combination. 3. patients had never received capecitabine before randomization. 4. patients voluntarily not using other products except for 10% urea cream and/or aloe vera gel for hand and feet.

Exclusion criteria

Exclusion criteria: 1.Patients with history of allergic to aloe vera gel or urea cream were not eligible. Patients with widespread skin condition such as diffuse systemic sclerosis, erythrodermic psoriasis.

Design outcomes

Primary

MeasureTime frame
Efficacy At least 3 weeks of first dose capecitabine CTCAE grade

Secondary

MeasureTime frame
Quality of life At least 3 weeks of first dose capecitabine Edit Remove DLQI score

Countries

Thailand

Contacts

Public ContactLucksika Wanichtanom

Falculty of Medicine, Vajira hospital,Navamindradhiraj University

lucksikawanich@gmail.com022443900

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026