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

NCT ID: NCT00661102

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

capecitabine [Xeloda]

Intervention Type DRUG

As prescribed

dexpantenol [Bepantol]

Intervention Type DRUG

As prescribed

2

Group Type ACTIVE_COMPARATOR

Corticosteroids

Intervention Type DRUG

As prescribed

capecitabine [Xeloda]

Intervention Type DRUG

As prescribed

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

As prescribed

capecitabine [Xeloda]

Intervention Type DRUG

As prescribed

Interventions

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Corticosteroids

As prescribed

Intervention Type DRUG

Placebo

As prescribed

Intervention Type DRUG

capecitabine [Xeloda]

As prescribed

Intervention Type DRUG

dexpantenol [Bepantol]

As prescribed

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Fortaleza, Ceará, Brazil

Site Status

Salvador, Estado de Bahia, Brazil

Site Status

Salvador, Bahia, Estado de Bahia, Brazil

Site Status

Taguatinga, Federal District, Brazil

Site Status

Goiânia, Goiás, Brazil

Site Status

Goiânia, Goiás, Brazil

Site Status

Belo Horizonte, Minas Gerais, Brazil

Site Status

Belo Horizonte, Minas Gerais, Brazil

Site Status

Teresina, Piauí, Brazil

Site Status

Niterói, Rio de Janeiro, Brazil

Site Status

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Natal, Rio Grande do Norte, Brazil

Site Status

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

Ijuí, Rio Grande do Sul, Brazil

Site Status

Lajeado, Rio Grande do Sul, Brazil

Site Status

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Itajaí, Santa Catarina, Brazil

Site Status

Barretos, São Paulo, Brazil

Site Status

Campinas, São Paulo, Brazil

Site Status

Jaú, São Paulo, Brazil

Site Status

Ribeirão Preto, São Paulo, Brazil

Site Status

Santo André, São Paulo, Brazil

Site Status

Santos, São Paulo, Brazil

Site Status

Santos, São Paulo, Brazil

Site Status

São José do Rio Preto, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

Sorocaba, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ML21419

Identifier Type: -

Identifier Source: org_study_id