Trial information
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
Status: Recruiting
Protocol number: ML21419
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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.
Brief summary: 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. Target sample size is 1200.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Hand-foot syndrome onset Time frame: Event driven
2. QoL C-30 score Time frame: Weeks 7, 13 and 17
Key secondary outcomes: 1. Adverse events Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/15/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
Brazil
- Belo Horizonte
- Campinas
- Caxias do Sul
- Florianopolis
- Fortaleza
- Goiania
- Ijuí
- Itajaí
- Jaú
- Lajeado
- Natal
- Niteroi
- Petrópolis
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Santo Andre
- Santos
- São José Do Rio Preto
- Sao Paulo
- Sorocaba
- Taguatinga
- Teresina
