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

NCT00661102 | Completed Phase 3

• 1 other identifier: ML21419
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 35

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Hand-foot syndrome onset

  Event driven

• QoL C-30 score

  Weeks 7, 13 and 17

Secondary Outcomes (1)

• Adverse events

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: capecitabine [Xeloda]; Drug: dexpantenol [Bepantol]

2

ACTIVE COMPARATOR

Drug: Corticosteroids; Drug: capecitabine [Xeloda]

3

PLACEBO COMPARATOR

Drug: Placebo; Drug: capecitabine [Xeloda]

Interventions

Corticosteroids DRUG

As prescribed

2

Placebo DRUG

As prescribed

3

capecitabine [Xeloda] DRUG

As prescribed

1; 2; 3

dexpantenol [Bepantol] DRUG

As prescribed

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• existence of clinical symptoms suggesting hand-foot syndrome;
• use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
• diabetes mellitus.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (35)

Unknown Facility

Fortaleza, Ceará, 60336-550, Brazil

Location

Unknown Facility

Salvador, Estado de Bahia, 41810-570, Brazil

Location

Unknown Facility

Salvador, Bahia, Estado de Bahia, 40170-380, Brazil

Location

Unknown Facility

Taguatinga, Federal District, 72115-700, Brazil

Location

Unknown Facility

Goiânia, Goiás, 74605-020, Brazil

Location

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Goiânia, Goiás, 74605-070, Brazil

Location

Unknown Facility

Belo Horizonte, Minas Gerais, 30150-320, Brazil

Location

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Belo Horizonte, Minas Gerais, 31190-131, Brazil

Location

Unknown Facility

Teresina, Piauí, 90430-001, Brazil

Location

Unknown Facility

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21020130, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 22745-130, Brazil

Location

Unknown Facility

Natal, Rio Grande do Norte, 59040150, Brazil

Location

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Caxias do Sul, Rio Grande do Sul, 95020-170, Brazil

Location

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Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

Location

Unknown Facility

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Unknown Facility

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Unknown Facility

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Unknown Facility

Barretos, São Paulo, 14784-400, Brazil

Location

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Campinas, São Paulo, 13083-888, Brazil

Location

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Jaú, São Paulo, 17210-080, Brazil

Location

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Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09060-650, Brazil

Location

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Santos, São Paulo, 11075-350, Brazil

Location

Unknown Facility

Santos, São Paulo, 11075-900, Brazil

Location

Unknown Facility

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01221-020, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04026-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04039-901, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 22793-080, Brazil

Location

Unknown Facility

Sorocaba, São Paulo, 18030-005, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Adrenal Cortex Hormones; Capecitabine; Pantothenic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Imides; Organic Chemicals; beta-Alanine; Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BR (35)