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

Breast Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661102
• Other study ID #: ML21419
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: November 1, 2016
• Start date: December 2008
• Est. completion date: April 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hand-Foot Syndrome

Intervention

Drug:
• Corticosteroids
As prescribed
• Placebo
As prescribed
• capecitabine [Xeloda]
As prescribed
• dexpantenol [Bepantol]
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand-foot syndrome onset		Event driven	Yes
Primary	QoL C-30 score		Weeks 7, 13 and 17	No
Secondary	Adverse events		Throughout study	No