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
Phase 2
Completed
- 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
- Registration Number
- TCTR20230411005
- Lead Sponsor
- avamindradhiraj University Research Fund
- Brief Summary
A combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 61
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy At least 3 weeks of first dose capecitabine CTCAE grade
- Secondary Outcome Measures
Name Time Method Quality of life At least 3 weeks of first dose capecitabineEdit Remove DLQI score