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

NCT00661102 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Corticosteroids

As prescribed

DRUG

Placebo

As prescribed

DRUG

capecitabine [Xeloda]

As prescribed

DRUG

dexpantenol [Bepantol]

As prescribed

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661102 on ClinicalTrials.gov