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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661102
First Posted: April 18, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Corticosteroids Drug: Placebo Drug: capecitabine [Xeloda] Drug: dexpantenol [Bepantol] Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hand-foot syndrome onset [ Time Frame: Event driven ]
  • QoL C-30 score [ Time Frame: Weeks 7, 13 and 17 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Throughout study ]

Enrollment: 598
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
As prescribed
Drug: dexpantenol [Bepantol]
As prescribed
Active Comparator: 2 Drug: Corticosteroids
As prescribed
Drug: capecitabine [Xeloda]
As prescribed
Placebo Comparator: 3 Drug: Placebo
As prescribed
Drug: capecitabine [Xeloda]
As prescribed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661102


Locations
Brazil
Salvador, Bahia, BA, Brazil, 40170-380
Salvador, BA, Brazil, 41810-570
Fortaleza, CE, Brazil, 60336-550
Taguatinga, DF, Brazil, 72115-700
Goiania, GO, Brazil, 74605-020
Goiania, GO, Brazil, 74605-070
Belo Horizonte, MG, Brazil, 30150-320
Belo Horizonte, MG, Brazil, 31190-131
Teresina, PI, Brazil, 90430-001
Niteroi, RJ, Brazil, 24033-900
Rio De Janeiro, RJ, Brazil, 21020130
Rio de Janeiro, RJ, Brazil, 22745-130
Natal, RN, Brazil, 59040150
Caxias do Sul, RS, Brazil, 95020-170
Caxias do Sul, RS, Brazil, 95070-560
Ijui, RS, Brazil, 98700-000
Lajeado, RS, Brazil, 95900-000
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90430-001
Porto Alegre, RS, Brazil, 90610-000
Itajai, SC, Brazil, 88301-220
Barretos, SP, Brazil, 14784-400
Campinas, SP, Brazil, 13083-888
Jau, SP, Brazil, 17210-080
Ribeirao Preto, SP, Brazil, 14048-900
Santo Andre, SP, Brazil, 09060-650
Santos, SP, Brazil, 11075-350
Santos, SP, Brazil, 11075-900
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04026-000
Sao Paulo, SP, Brazil, 04039-901
Sao Paulo, SP, Brazil, 22793-080
Sorocaba, SP, Brazil, 18030-005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661102     History of Changes
Other Study ID Numbers: ML21419
First Submitted: April 16, 2008
First Posted: April 18, 2008
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Breast Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Drug Eruptions
Dermatitis
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents