Testing moisturising creams for skin reactions in cancer patients
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 study is testing three different moisturizing creams to see which one helps cancer patients with skin reactions caused by their treatment feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sarawak General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kuching, Sarawak) |
| Trial ID | NCT05939726 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of three different moisturising creams in patients undergoing capecitabine-based cancer therapy who develop palmar-plantar erythrodysesthesia (PPE). Participants will be randomly assigned to receive either a cream with palm-oil-derived vitamin E, a cream without vitamin E, or a urea-based cream alone. The study will assess the severity of PPE, symptoms, quality of life, and any adverse events over a treatment period of nine to eighteen weeks. Both patients and investigators will be blinded to the cream assignments to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving capecitabine therapy and have developed grade 1 PPE.
Not a fit: Patients with a history of allergy to vitamin E or its components, or those with other dermatological conditions that could interfere with the study, may not benefit.
Why it matters
Potential benefit: If successful, this study could provide effective relief from skin reactions associated with cancer treatment, improving patients' quality of life.
How similar studies have performed: While similar approaches have been explored, this specific combination of treatments in the context of capecitabine-induced PPE is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kuching, Sarawak
- Sarawak General Hospital — Kuching, Sarawak, Malaysia (Recruiting)
Study contacts
- Principal investigator: Pei Jye Voon, M.D — Sarawak General Hospital
- Study coordinator: Teck Long King, BPharm(Hons)
- Email: kingtl@crc.moh.gov.my
- Phone: 60168911615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.