A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Corticosteroids; Drug: Placebo; Drug: dexpantenol [Bepantol]; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661102

ML21419

Details and patient eligibility

About

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.

Enrollment: 598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

598 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: capecitabine [Xeloda]

Drug: dexpantenol [Bepantol]

2

Active Comparator group

Treatment:

Drug: capecitabine [Xeloda]

Drug: Corticosteroids

3

Placebo Comparator group

Treatment:

Drug: capecitabine [Xeloda]

Drug: Placebo