Clinical trial · Interventional
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal 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)
This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| Corticosteroids | Drug | — | UNRESOLVED |
| dexpantenol [Bepantol] | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: capecitabine [Xeloda]
- Drug: dexpantenol [Bepantol]
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: Corticosteroids
- Drug: capecitabine [Xeloda]
- type
- PLACEBO_COMPARATOR
- label
- 3
- interventionNames
- Drug: Placebo
- Drug: capecitabine [Xeloda]
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * breast cancer or colorectal cancer patients; * treated with oral Xeloda for \<=5 days; * lack of hand-foot syndrome (palmar-plantar erythrodysesthesia). Exclusion Criteria: * existence of clinical symptoms suggesting hand-foot syndrome; * use of doxorubicin, 5-FU and/or cytarabine for last 3 months; * diabetes mellitus.
References
Publications (0)
Data not yet available