Clinical trial · Expanded Access
A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®. Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mapisal | Device | — | UNRESOLVED |
| Urea hand-foot cream | Other | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent 2. Male or female ≥18 years of age 3. Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine according to label 4. Palliative or adjuvant chemotherapy with capecitabine (combination- or mono-therapy, minimal dose of capecitabine 2000 mg/m2) 5. Life expectancy of least 12 weeks 6. WHO performance status 0-2 7. Adequate contraception 8. Willingness to fill in QoL forms 9. Laboratory requirements * Platelet count ≥100 × 109/L * Leukocyte count \> 3.0 × 109/L * Hemoglobin ≥ 10.0 g/dL 10. Resolution of all chemotherapy- or radiotherapy-related toxicities to grade 1 or lower except for stable sensory neuropathy \< grade 2. Any dermatological toxicities other than alopecia resulting from previous chemotherapy or radiotherapy must be completely resolved. Exclusion Criteria: 1. Previous chemotherapy with capecitabine or liposomal doxorubicine, or any other substance, i.e. tyrosine kinase inhibitors (such as sorafenib and sunitinib) that may induce HFS 2. Radiotherapy or surgery within 4 weeks before start of treatment. 3. Dermatologic diseases that could interfere with the result of the clinical trial 4. Known drug/ alcohol abuse 5. Pregnant or breast feeding patients 6. Participation in another clinical trial and patient received investigational drug within the last 30 days prior to treatment start (i.e. follow-up within a preceding trial is not exclusionary) 7. Known allergic reactions to any of the ingredients of the ointments or capecitabine
References
Publications (1)
- DERIVEDHofheinz RD, Gencer D, Schulz H, Stahl M, Hegewisch-Becker S, Loeffler LM, Kronawitter U, Bolz G, Potenberg J, Tauchert F, Al-Batran SE, Schneeweiss A. Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. J Clin Oncol. 2015 Aug 1;33(22):2444-9. doi: 10.1200/JCO.2014.60.4587. Epub 2015 Jun 29. PMID 26124485